published by - .: mida · 2018-02-12 · published by: malaysian investment development authority...
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Published by:
Malaysian Investment Development AuthorityMIDA Sentral, No.5, Jalan Stesen Sentral 550470 Kuala Lumpur, MalaysiaTel: (603) 2267 3633 Fax: (603) 2274 7970Website: www.mida.gov.myE-mail: [email protected]
Malaysia
Your Profit Centre in Asia
Kuala Lumpur
www.mida.gov.my
This guidebook for the pharmaceuticalindustry in Malays ia serves as animportant source of in format ion forinvestors intending to invest in th isi n d u s t r y. I t a l s o s p e l l s o u t t h eprocedures and requirements for thevar ious appl icat ions for l icences andpermits for the setting up of a businessin the pharmaceutical industry.
The Malaysian Investment DevelopmentAuthor i ty (MIDA) is the Government'sprincipal agency under the Ministry ofInternational Trade and Industry (MITI)responsib le for the promot ion andcoordination of industrial developmentin Malaysia. MIDA assists companiesw h i c h i n t e n d t o i n v e s t i n t h emanufacturing and services sectors inthe country. MIDA has a global networkof 24 overseas off ices covering NorthAmerica, Europe, Asia Pacific and Africato ass ist investors. W ith in Malays ia,MIDA has 12 branch off ices in thevarious states to faci l i tate investors inthe implementat ion and operat ion oftheir projects.
For more informat ion on investmentopportunit ies in Malaysia and contactdetails of MIDA, visit www.mida.gov.my.
Published by
Preface
ContentsFact Sheet of Malaysia 2- Background of Malaysia- Key Economic Indicators
Healthcare in Malaysia 3- The Pharmaceutical Industry in Malaysia- Investment Opportunities- Infrastructure Support- Intellectual Property (IP) Protection
Why Malaysia 12
Getting Started in Malaysia 13- Starting a Business - Taxation- Approval of Manufacturing Projects - Approval of Expatriate Posts
Incentives for Investment 18- Incentives for Manufacturing Companies- Incentives for High Technology Companies- Incentives for Strategic Projects- Incentives for Research & Development (R&D)- Incentives for Operational Headquarters (OHQ)- Incentives for International Procurement Centres (IPC) /
Regional Distribution Centres (RDC)- Other Incentives
Regulatory Control in the Pharmaceutical Industry 21- Regulatory Agency - Drug Control Authority- Product Registration - New Application Processing Procedures - Application Formalities - Application Processes - Regulatory Outcome - Registration Maintenance - Online Registration System - Licence Issued for Registered Products - Manufacturer’s Licence Application Procedures - Bioavailability and Bioequivalence Study for
Pharmaceutical Products
Useful Contacts 45- MIDA Overseas Offices- MIDA State Offices- MITI Overseas Offices- MATRADE Overseas Offices- MATRADE State Offices- Ministry of Health and Relevant Division/Agencies
KUALA LUMPUR
PERLIS
KEDAH
PULAU PINANG
PERAK
SELANGOR
MELAKA
JOHOR
KELANTAN
PAHANGNEGERI
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2 Fact Sheet of Malaysia
Malaysia covers an area of about 330,252 square kilometres, consisting of13 states, namely Johor, Kedah, Kelantan, Melaka, Negeri Sembilan,Pahang, Perak, Perlis, Penang, Sabah, Sarawak, Selangor and Terengganu.Apart from the 13 states, there are three Federal Territories, which are KualaLumpur, Putrajaya and Labuan. Kuala Lumpur is the capital of Malaysia.Malaysia l ies entirely in the equatorial zone and the average dailytemperature throughout Malaysia varies from 21°C to 32°C.
Malaysia is a multi-ethnic country. The principal ethnic groups are Malays,fol lowed by Chinese and Indians. Other signif icant groups are theindigenous people of Sarawak and Sabah, including the Dayaks, Kadazans,Bajaus, Melanaus and Muruts.
Major exports of Malaysia are manufactured goods such as electrical andelectronics products, machinery and appliances, chemicals, plasticproducts, iron, steel and metal products, and petroleum-based products.In the year 2010, the share of exports of manufactured goods to totalexports is 72%. Imports comprise mainly intermediate goods such asprimary and processed industrial supplies, thermionic valves and tubes,parts and accessories of capital goods, primary and processed fuellubricants, and parts and accessories for transport equipment.
Background of Malaysia
Key Economic Indicators
f: forecastSources: Economic Report 2012/13Exchange rate: USD1 = RM3.09 (as at January 2013)
2013 f
Population 29.71 million
Labour force 13.2 million
Unemployment rate 3.1%
GDP RM780.98 billion (USD253.56 billion)
GDP growth 4.5% - 5.5%
Per capita income RM32,947 (USD10,662)
Inflation rate (CPI) 1.9% (2012)
Total export (f.o.b.) RM740.7 billion
Total import (c.i.f.) RM639.9 billion
Healthcare in Malaysia 3
Malaysia’s primary care model has been acknowledged by the World HealthOrganisation as a viable system to achieve “Health for All”. The demand forquality healthcare continues to rise in Malaysia with increasing affluence andrising consumer awareness. Currently, about 7.25% of the country’s GDP isexpected to be spent on healthcare. This is expected to increase with thegrowing population and a longer life expectancy, as well as the Government’sincreasing expenditures on provision of better healthcare facilities and services.
Healthcare remains a priority of the Malaysian Government. For 2012, theGovernment had increased the budget allocation for healthcare to RM16.87bi l l ion. A total RM1.87 bi l l ion for the budget wi l l be spent on healthcaredevelopment to enhance health faci l i t ies and provide medical equipment,increase supply of medicines, develop human resources, intensify research andenforcement activities, as well as to build more hospitals, clinics and quarters.
Crude Birth Rate (per 1000 population) 17.5*
Crude Death Rate (per 1000 population) 4.8*
Infant Mortality Rate (per 1000 live births) 6.8*
Life Expectancy - Male (age in years) 71.9*
Life Expectancy - Female (age in years) 77.0*
Healthcare in Malaysia
Demographics - 2011
Number of registered doctors (Government & Private) 36,607
Population per doctor 791
Number of hospitals 366*
Number of clinics 11,212**
Number of beds 55,923
Number of dental chairs 486***
Health Facts
* Includes Government hospitals, special medical institutions, non-MOH Government hospitals& private hospitals.
** Includes MOH dental clinics, MOH mobile dental clinics (including mobile and pre-schoolteam); MOH Health Clinics, MOH Community Clinics, MOH maternal & child health clinics,MOH mobile health clinics, private medical clinics & private dental clinics.
***Includes MOH dental clinics and MOH mobile dental clinics.
Source: Ministry of Health Malaysia, (as at July 2012)
* Provisional/Preliminary data (as of 2010)
4 Healthcare in Malaysia
The pharmaceutical industry is one of the new growth areas targeted forpromotion and development by the Government. The products manufacturedby the Malaysian pharmaceutical industry are broadly categorised into fourcategories, i .e prescript ion medicines, over-the-counter (OTC) products,tradit ional medicines and health/food supplements. The pharmaceuticalcompanies are mainly small and medium-sized companies engaged in theproduction of generic drugs, traditional medicines and herbal supplements aswell as contract manufacturing for foreign multinational corporations (MNCs).
According to the Drug Control Authority (DCA) ofthe Ministry of Health, as of October 2012, thereare 259 manufacturing companies licenced byDCA compris ing 182 tradit ional medicinecompanies, 75 pharmaceutical companies and3 veterinary product companies.
Among the major local companies arePharmaniaga Manufactur ing Berhad, HovidBerhad, CCM Duopharma Biotech Sdn Bhd, andKotra Pharma (M) Sdn Bhd. These companiesfocus mainly on generic drugs, part icular lyan t ib io t i cs , pa ink i l l e rs , hea l th supplementsand injectables. Some of the foreign-ownedcompanies with manufacturing presence in thecountry include Y.S.P. Industries (M) Sdn Bhd(Taiwan), Ster l ing Drug (M) Sdn Bhd (themanufacturing arm of GlaxoSmithKline from UK),Ranbaxy (M) Sdn Bhd ( India), Xepa-SoulPatt inson (M) Sdn Bhd (Singapore) and SMPharmaceutical Sdn Bhd (India).
The large MNCs such as Pf izer, Schering Plough, Novart is, El i Li l ly, AstraZeneca are mainly l icenced importers. Their products, which are most lybranded drugs, are distributed by locally incorporated companies.
The Malaysian pharmaceutical industry has the capability to produce almost alldosage forms, including ster i le preparat ions such as eye preparat ions,injections, soft gelatine capsules and time release medications. In January2002, Malaysia was admitted as the 26t h member of the PharmaceuticalInspection Cooperation/Scheme (PIC/S)*. This would faci l i tate exports ofMalaysian pharmaceutical products to the member countries which include EU,Australia and Canada.
The Pharmaceutical Industry in Malaysia
* The PIC/S provides an active and constructive co-operation in the field of GoodManufacturing Practice(GMP) between countries and pharmaceutical inspection authorities.It leads the international development, implementation and maintenance of harmonised GMPStandards and Quality System of Inspectorates in the field of medical products.
Healthcare in Malaysia 5
Biopharmaceuticals / Biogenerics (Biosimilars)The potential expansion of biosimilars is expected to have a major implicationon the biopharmaceutical industry. The impact of biosimilars on thebiopharmaceutical industry is expected to be similar if not greater than the impactof generics on the pharmaceutical industry. Currently biopharmaceuticals areconsiderably more expensive than conventional medications. However, Malaysiaoffers a more competitive cost option to investors due to the available ecosystem.
A large number of first generation biopharmaceutical products are nearing maturityand major biopharmaceutical companies are likely to move these out to countrieslike Malaysia that offer a good value preposition.
Currently, in Malaysia, local and foreign players arealready engaged in activities like biopharmaceutical APIs,FDA / EMEA cGMP compliant services, specialising inmonoclonal antibodies and recombinant proteins. Inaddition, special ised research, development andcommercialisation of biopharmaceutical products is on-going. The government is further encouraging potentialinvestors to move up the value-chain.
Contract ManufacturingThe current trend among the major global drug companies is to outsource theirmanufacturing operations to enable them to concentrate on time consuming andcostly `gene hunting’ methods of R&D for new drug discovery. The pharmaceuticalindustry in Malaysia could capitalise on this development by manufacturing genericand patented products of these companies on contract basis. A number of localcompanies are keen to provide contract manufacturing services to interested parties.
Generic DrugsForeign pharmaceutical companies are encouraged to set up faci l i t ies inMalaysia to manufacture off-patented drugs.
Herbal MedicinesForeign pharmaceutical companies could enter into collaborations with localcompanies and research institutions to produce new medicinal drugs.
Manufacturing of Active Pharmaceutical Ingredients (API)There is huge demand for API to be used in the manufactur ing of localpharmaceuticals as well as for export.
Other higher value-added products and servicesThe products include innovator drugs, vaccines, biopharmaceuticals, inhalationproducts drug discovery activit ies or new chemical entity (NCE) and noveldelivery systems.
Investment Opportunities
6 Healthcare in Malaysia
Infrastructure Support
Efficient Logistics and Well-DevelopedInfrastructureThe pr ime advantage to
manufacturers in Malaysia has
been and continues to be the
nat ion's persistent dr ive to
develop and upgrade i ts
infrastructure. Integrated
logist ics have ensured that
Malaysia's pharmaceutical
products reach markets in Asia
and worldwide on time, enabled by the extensive infrastructure that includes
world-class airports, seaports and sophisticated telecommunications network.
Availability of IndustrialEstates and SpecialisedParksIndustries in Malaysia are mainly
located in over 200 industr ia l
estates or parks and 13 Free
Industr ial Zones (FIZs) developed throughout the country. FIZs are export
processing zones which have been developed to cater to the needs of export-
oriented industries such as pharmaceutical industry. Companies in FIZs are
allowed duty free imports of raw materials, components, parts, machinery and
equipment directly required in the manufacturing process. In areas where
FIZs are not avai lable, companies can set up Licenced Manufactur ing
Warehouses (LMWs) which are accorded facilities similar to those enjoyed by
establishments in FIZs.
Malaysia has also developed specialized parks to cater to the needs of specific
industries which are technology-intensive and research-intensive. Examples of
these parks are the Technology Park Malaysia in Bukit Jal i l , Kuala Lumpur
and the Kul im Hi-Tech Park in the northern state of Kedah. These parks
comprise state-of-the-art buildings with specific functions and fully-integrated
high technology park.
Healthcare in Malaysia 7
Other specialised parks developed by the Malaysian Government agencies are
as follows:
Bio-XCell MalaysiaBio-XCell is a premier biotechnology park and ecosystem dedicated to healthcare
and industrial biotechnology developed by Malaysian Bio-XCell Sdn. Bhd. (a joint
venture company formed between BiotechCorp and UEM Land Berhad).
Bio-XCell is strategically located on 160 acres in Nusajaya, within the Iskandar
region of Johor, Malaysia, and close to the border with Singapore providing global
connectivity through a network of five seaports and two international airports,
all within 59 km. Bio-XCell offers an environment conducive for the development
and manufacturing of biologics, pharmaceuticals, bio-based/green chemicals and
other solutions to heal, fuel and green the world. As a managed park, Bio-XCell
provides its clients and investors with a range of value added benefits including
comprehensive infrastructure, high speed internet access, park maintenance and
security as well as core facilities to nurture the ecosystem.
Key facilities of the park include:
Central Hub: A multipurpose complex with a variety of office and lab space
for rent. The focal point of the park providing amenit ies such auditor ium,
business centre, training facilities, Food & Beverage and retail outlets.
Central Utilities Facility: Providing uti l it ies for biomanufacturing such as
industrial steam, chil led water and waste water treatment service to clients
on a user pays basis.
Perlis
Kedah
Penang
KelantanPerak
Terengganu
Enstek
Nusajaya
M A L A Y S I APahang
Selangor
Kuala Lumpur
N. Sembilan
MelakaJohor Sarawak
Sabah
TechnologyPark Malaysia
Kulim Hi-TechPark
For further information on Bio-XCell,visit www.bio-xcell.my
8 Healthcare in Malaysia
Standard Shells: These buildings providing 20,000 sq. ft. of space, can be
fit-out to clients’ needs and are available for rent or purchase.
Plots of freehold land: Available for sale, enabling clients to build their own
customised facilities.
Penang Science ParkPenang Science Park is designed with good infrastructure and amenities to
cater for strategic industries such as high technology, biotechnology, halal
industries and SMI park.
The park consists of 3 phases;
• The first phase spans with an area of 121 hectares at Batu Kawan and has
been completed with infrastructure and amenities,
• The second phase will cover an area of 121 hectares at Bukit Minyak and
the infrastructure is expected to complete by mid 2013.
• The final phase is scheduled to be ready in the year 2014.
A total of 48 acres has been allocated for
the biotechnology and pharmaceutical
industries.
Kulim Hi-Tech Park (KHTP)The Kulim Hi-Tech Park (KHTP), officially opened in 1996, is the first Hi-Tech Park
in Malaysia. The KHTP is situated in the district of Kulim, in the state of Kedah, in
the north-west of Peninsular Malaysia. Currently, the development of KHTP covers
an area of approximately 1,700 hectares (approximately 4,000 acres).
For further information onPenang Science Park, visit www.pdc.gov.my
Facilities / Centres Distance / Driving Time
Penang International Airport 42 km (40 minutes)
Penang Port (Butterworth) 23 km (20 minutes)
North-South Highway 5 km (5 minutes)
Urban centres 19 km (20 minutes)
Butterworth 10 km (15 minutes)
Seberang Jaya 5 km (5 minutes)
Batu Kawan (new township)
University Technology Mara 10 km (10 minutes)
University Science Malaysia 20 km (25 minutes)
Japan Malaysian Tech. Institute within the park
Healthcare in Malaysia 9
The KHTP is conceived and developed as one of the national strategies of
Vision 2020 for Malaysia to become a ful ly- industr ial ised nation by 2020.
Envisioned to be the ‘Science City of The Future’, the KHTP has continually
being developed and promoted as an integrated science park targeting clean,
capital-intesive, and high value-added technology-related industries primarily
in the f ie lds of advanced electronics, mechanical e lectronics,
telecommunicat ions, semiconductors, optoelectronics, biotechnology,
advanced materials, research and development and emerging technologies.
Right from the onset, the development of KHTP incorporates 6 elements or
Zones, namely:
• industrial;
• R&D and training;
• amenity;
• housing;
• urban; and
• institutional.
Kulim Technology Park Corporation Sdn Bhd (D-44351), a whole-subsidiary of
the Kedah State Development Corporation, is the developer and manager of
the KHTP; while the Malaysian Federal Government fully supports the KHTP
development by way of dedicated
development funds, as well as, other
cr i t ical advisory and promotion
support.
Enstektechpark@enstek is current ly the
technology park with the highest number
of Biotechnology and Medical Industrial
Companies in Malaysia.
Located within the township of Bandar
Enstek, techpark@enstek is just 10 minute
away from Kuala Lumpur Internat ional
Airport (KLIA) and only 38 minutes from
downtown Kuala Lumpur via the Express
Rail Link (ERL).
Bandar Enstek consists of 4 main components; residential area, technology
land park, commercial hub and institutional zones.
SELANGOR
MELAKA
JOHOR
PAHANG
NEGERISEMBILAN
ENSTEK Technology Park
For further information on Kulim Hi – Tech Park, visit www.khtp.com.my
10 Healthcare in Malaysia
techpark@enstek is envisaged to become a world-class technology hub catering
for the need of high technology and eco-conscious industries such as
biotechnology, green technology
and information technology (ICT)
industries. It is also endowed with
ready infrastructure and amenities
to support such sectors.
Availability of Clinical Trials and Bioequivalence CentresThe Clinical Research Centre (CRC), comprising a network of 17 centres aroundthe country, acts as a one-stop-centre by providing a single point of contact toaccess all Ministry of Health hospitals and clinics to conduct clinical trials inMalaysia. These clinical trial centres have linkages to more than 50 general anddistrict hospitals, and more than 100 health clinics as potential sites for clinicaltr ials with access to 550 cl inical investigators and 17 mil l ion patients fromdiverse therapeutic areas in the public healthcare system in Malaysia.
The private entities which conduct clinical trials are as follows:-
• Infokinetics Research Centre Sdn. Bhd.
• International Medical University
• University Malaya Medical Centre
• NCI Hospital
• Universiti Kebangsaan Malaysia Medical Centre
• Hospital Universiti Sains Malaysia
• Sunway Medical Centre
• Universiti Teknologi Mara, Selayang and Sungai Buloh
• Mahkota Medical Centre
• Lam Wah Ee Hospital
• Mount Miriam Cancer Hospital
• Gleneagles Medical Centre
• Columbia Asia Medical Centre
• Island Hospital
• Penang Adventis Hospital
• Pantai Hospital Penang
• Loh Guan Lye Specialist Centre
• Monash University Sunway Campus & Johor Bahru Campus
Bioequivalence Centres
• University Malaya Medical Centre
• School of Pharmaceutical Sciences,
Hospital Universiti Sains Malaysia
• Infokinetics Research Centre Sdn Bhd
For further information on Enstek, visitwww.techpark.enstek.com
Healthcare in Malaysia 11
Intellectual Property (IP) Protection
Malaysia has strong IP protection in place and is committed to safeguarding IPon inventions. To ensure IP protection in Malaysia is in line with internationalstandards and provides protection for both local and foreign investors, Malaysiais a party to the following treaties:
• World Intellectual Property Organisation (WIPO), 1967;
• Paris Convention for the Protection of Industrial Property 1883;
• Berne Convention for the Protection of Literary and Artistic Works (1886);
• Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement;
• Patent Cooperation Treaty (PCT) 1970
For further informationon IP protection inMalaysia, visitwww.myipo.gov.my
IP in Malaysia comprises:
• Patents
• Trade Marks
• Industrial Designs
• Copyrights
• Geographical Indications
• IC Layout Designs
12 Why Malaysia
“Why Malaysia”
An Educated Workforce
• Talented, young, educated andproductive workforce
• Multilingual workforce speaking twoor three languages, including English
• Comprehensive system of vocationaland industrial training, includingadvanced skills training.
• Harmonious industrial relations withminimal trade disputes
Developed Infrastructure
• Network of well-maintained highways
and railways
• Well-equipped seaports and airports
• High qual i ty te lecommunicat ions
network and services
• Fully developed industrial parks,
including free industrial zones,
technology parks and Multimedia
Super Corridor (MSC)
• Advanced MSC Malaysia Cybercities
and Cybercentres
Vibrant Business Environment
• Market-oriented economy
• Well-developed financial and banking
s e c t o r, i n c l u d i n g t h e L a b u a n
International Financial Exchange
• Wide use of English, especially in
business Legal and account ing
practice based on the British system
• Large local business community with
a long history in international
business links
• Large foreign business community in
all business sectors
• Extensive trade links - country's total
trade was valued at RM1.31 trillion
(2012)
Supportive Government Policies
• Pro-business policies
• Responsive government
• Liberal investment policies
• Attractive tax and other incentives
• Liberal exchange control regime
• Intellectual property protection
Quality of Life
• Friendly and hospitable Malaysians
• Safe and comfortable living
environment
• Excellent housing, modern amenities,
good healthcare and medical
facilities
• Excellent educational institutions
including international schools for
expatriate children
• World-class recreational and sports
facilities
• Excellent shopping with goods from
all over the world
Getting Started in Malaysia 13
Getting Started in Malaysia
Starting a BusinessIn general, the overall cost of doing business in Malaysia is competit ive. InMalaysia, the process is facilitated by experienced and reputable agencies thatexist both within and outside the Federal and local governments. For startinga business in Malaysia, the main fees which need to be paid are fees to theCompanies Commission of Malaysia (SSM) and fees for company secretarialservices.
Main fees to be paid to the Companies Commission of Malaysia
USD1 = RM3.08 (As at January 2013)Source: Companies Act, 1965 (Act 125) & subsidiary legislations.For the full range of fees, please visit SSM website at www.ssm.com.my
Other costs of doing business in Malaysia that investors need to know are rentalrates for prime office space, cost of industrial land, cost of ready-built factoryand average construction costs of factory building. The costs will depend onthe business location selected by the investors. For example, if it is in KualaL u m p u r, t h e r e n t a l r a t e f o rp r i m e o f f i ce space i s i n therange of RM64.60 - RM102.25(USD20.77 – USD32.88)/squaremetre/month.
RM USD
Reservation of a name 30 9.74
For registration of a company, fees range according to nominal share capital, e.g.:
- Below RM100,000 1,000 324.68
- RM100,001 - RM500,000 3,000 974.03
- RM500,001 - RM1,000,000 5,000 1,623.38
- RM1,000,001 - RM5,000,000 8,000 2,597.40
- RM5,000,001 - RM10,000,000 10,000 3,246.75
- RM10,000,001 - RM25,000,000 20,000 6,493.51
- RM25,000,001 - RM50,000,000 40,000 12,987.01
- RM50,000,001 - RM100,000,000 50,000 16,233.77
- Exceeding RM100 million 70,000 22,727.27
For more details on these costs,visit www.mida.gov.my
14 Getting Started in Malaysia
Registration of Business/Incorporation of Company
• Sole proprietorships • Partnerships• Company
Companies Commission ofMalaysia (SSM)www.ssm.com.my
Application for ManufacturingLicences and/or Tax Incentives
Malaysian InvestmentDevelopment Authority (MIDA)www.mida.gov.my
Application for Other Approvals and Permits
Approvals at the Level of Federal Ministries / Departments / Agencies
• Good Manufacturing Practice(GMP) & Registration ofProducts from NationalPharmaceutical ControlBureau (NPCB), Ministry of Health(www.bpfk.gov.my)
• Department of OccupationalSafety and Health(www.dosh.gov.my)
• Fire and Rescue Department (www.bomba.gov.my)
• Department of Environment(www.doe.gov.my)
Approvals at the Level of State Governments and Local Authorities
• Acquire land and premise(Industrial land /Premise /Factory Approval)
• No Objection Letter (NOL) forlocation of projects
• Planning Permits
• Building Plans
• Certificate of Fitness (CF)
• Business Licence
• Electricity supply - Tenaga Nasional Berhad(www.tnb.gov.my)
• Water supply - Local Water Authority
(www.jba.gov.my)
• Telecommunication - Telekom Malaysia Berhad(www.tm.com.my)
Utilities
• Expatriates - MIDA (www.mida.gov.my) or
Immigration Department (www.imi.gov.my)
• Foreign Workers - Immigration Department
(www.imi.gov.my)
Immigration
Getting Started in Malaysia 15
Taxation
Generally, all income of companies and individuals accrued in or derived fromsources outside Malaysia and received in Malaysia is liable to tax. However,effective from the year of assessment 2004 income remitted to Malaysia byresident companies (other than companies carrying on the business of banking,insurance, air and sea transportat ion), resident indiv iduals, non-residentcompanies and non-resident individuals are exempted from tax.
Income tax in Malaysia is assessed on income earned in the current year. Theself-assessment system was implemented for companies, sole proprietors,partnerships, cooperat ives and salar ied groups to streamline the taxadministration system.
Source: Inland Revenue Board – www.hasil.org.myUSD1 = RM3.08 (As at January 2013)
Corporate Tax
Resident and non-resident companies 25%
Resident companies with paid-up capital of RM2.5 million (USD811,688.31) and less at the beginning of the basis periodfor a year of assessment
• on the first RM500,000 (USD162,337.67) chargeable income 20%
• on subsequent chargeable income 25%
Personal Income Tax
Resident individuals with chargeable income of RM16,667 1%-26%
(USD5,411.36) and above per annum (after deduction of personal reliefs)
Non-resident individuals (not entitled to any personal reliefs) 26%
Withholding Tax (Non-resident persons)
Special classes of income (use of moveable property, technical 10%
services, installation services on the supply of plant and machinery, etc.)
Interest 15%
Royalty 10%
Contract payment on:
- account of contractor 10%
- account of employee 3%Other income such as commission, guarantee fees, 10%agency fees, brokerage fees, introducers fees etc.
16 Getting Started in Malaysia
Sales Tax
Sales tax is imposed on certain imported and locally manufacturedgoods under the Sales Tax Act, 1972. The tax rate ranges from 5 - 10%for majority of the goods except for food preparations other thanalcoholic and non-alcoholic compound preparations (other than thoseof heading No. 33.02) used for making beverages which falls under thetariff code 2106.90.490 with a tax rate of 20%. Sales tax is also imposedon petroleum and petroleum products according to specific rates.
5%-10%
Service Tax
Service tax is imposed on taxable services provided by taxable personsunder the Service Tax Act, 1975. Services include services provided byprofessionals (such as lawyers, engineers, architects, surveyors,consultants), advertising firms, private hospitals, insurance companies,communication companies, hotels and restaurants.
6%
Rates of Capital Allowances
Capital a l lowances are given on qual i fy ing capital expenditure. In i t ia lallowances are given only once while annual allowances are given every yearby the straightline method. Some of the items accorded allowances are shownbelow. For plant and machinery, companies are advised to verify with theInland Revenue Board on the specific items which qualify.
Initial Allowance Annual Allowance
Industrial buildings 10% 3%
Plant and machinery 20% 14%
Heavy machinery and motor vehicles 20% 20%
Computer and IT equipment 20% 40%
Environmental control equipment 40% 20%
Others 20% 10%
Source: Royal Malaysian Customs - www.customs.gov.my
Source: Inland Revenue Board - www.hasil.org.my
Getting Started in Malaysia 17
Approval of Manufacturing Projects
The Industrial Co-ordination Act 1975 (ICA) requires companies manufacturingpharmaceutical products with shareholders' funds of RM2.5 million and aboveor engaging 75 or more full-time paid employees to apply for a manufacturinglicence for approval by the Ministry of International Trade and Industry (MITI).
Foreign investors can now hold 100% of the equity in all investments in new projects,as well as investments in expansion/diversification projects by existing companies.
Malaysia's commitment in creat ing a safe investment environment hasconvinced more than 4,000 international companies from over 50 countriesto make Malaysia their offshore base.
A company whose equity participation has been approved will not be required torestructure its equity at any time as long as the company continues to complywith the original conditions of approval and retain the original features of the project.
Approval of Expatriate Posts
Manufacturing companies are allowed to bring in expatriate personnel where there is ashortage of trained Malaysian is well to safeguard their investment in the country. i.e“time posts” and “key posts”. Key posts refer to posts that are permanently filled byforeigners. The current guidelines on the employment of expatriate personnel formanufacturing companies are as follows:
Foreign paid-up capital of USD2 million and above:
• A maximum of 10 expatriate posts, including five key posts.• Can be employed for up to a maximum of 10 years for executive posts*, and 5 years
for non-executive posts**
Foreign paid-up capital of more than USD200,000 but less than USD2 million:
• A maximum of five expatriate posts, including at least one key post.• Can be employed for up to a maximum 10 years for executive posts*, and 5 years
for non-executive posts**
Foreign paid-up capital of less than USD200,000:
• Key posts can be considered where the foreign paid-up capital is at least RM500,000.• Time posts can be considered for up to 10 years for executive posts* and 5 years for
non-executive posts**• The number of key posts and time posts allowed depends on the merits of each case
* that require professional qualifications and practical experience** that require technical skills and experience.
18 Incentives for Investment
Incentives for Investment
The manufacturer of pharmaceuticals and related product is categorised as “promotedactivities” or “promoted products”. The list of promoted activities and products isavailable in MIDA website at www.mida.gov.my
Some of major tax incentives available for the pharmaceutical industry are as follows:-
• Incentives for Manufacturing Companies
• Incentives for High Technology Companies
• Incentives for Strategic Projects
• Incentives for Research & Development (R&D)
• Incentives for Operational Headquarters (OHQ)
• Incentives for International Procurement Centres (IPC) / Regional Distribution Centres(RDC)
• Other incentives
Incentives for Manufacturing Companies
• Pioneer Status with income tax exemption of 70% or 100% on statutory income fora period of 5 years, or
• Investment Tax Allowance (ITA) of 60% or 100% on qualifying capital expenditureincurred for a period of 5 years, or
• Reinvestment Allowance (RA) of 60% on qualifying capital expenditure (to be offsetagainst 70% or 100% of statutory income) for 15 consecutive years
Incentives for High Technology Companies
• Pioneer Status with full income tax exemption on statutory income for 5 years, or
• ITA of 60% on qualifying capital expenditure for 5 years to be offset against 100% ofstatutory income
Incentives for Strategic Projects
• Pioneer Status with full income tax exemption on statutory income for 10 years, or
• ITA of 100% on qualifying capital expenditure for 5 years to be offset against 100%of statutory income
Incentives for Investment 19
Incentives for Research & Development (R&D)
Contract R&D Company
• Pioneer Status with 100% income tax exemption on statutory income for 5 years, or
• ITA of 100% on qualifying capital expenditure for 10 years to be offset against 70%of statutory income
R&D Company
ITA of 100% on qualifying capital expenditure for 10 years to be offset against 70% ofstatutory income
In-house Research
Investment Tax Allowance of 50% on qualifying capital expenditure for 10 years to beoffset against 70% of statutory income
Incentives for Operational Headquarters (OHQ)
• 100% income tax exemption for a period of 10 years for income derived from business,interest and royalties
• Dividends paid from the exempt income will be exempted from tax
• The income generated by an OHQ company in providing qualifying services to itsrelated companies in Malaysia will not be taxed during its tax-exempt period, providedsuch income does not exceed 20% of its overall income derived by providing qualifyingservices
• Expatriates working in OHQ companies are taxed only on the portion of theirchargeable income attributable to the number of days that they are in Malaysia
• Import duty and sales tax exemption
Incentives for International Procurement Centres (IPC) /Regional Distribution Centres (RDC)
• Full tax exemption of statutory income for 10 years
• Dividends paid from the exempt income will be exempted from tax in the hands ofshareholders
• Expatriates working in IPC/RDC companies are taxed only on the portion of theirchargeable income attributable to the number of days that they are in Malaysia
20 Incentives for Investment
Other Incentives
i. Incentives for Export
• Double Deduction for the Promotion of Export
• Single Deduction for the Promotion of Export
• Double Deduction on Export Credit Insurance Premium
• Special Industrial Building Allowance for Warehouses
• Double Deduction on Freight Charges
• Incentive for the Implementation of RosettaNet
• Double Deduction for the Promotion of Malaysian Brand Names
ii. General Incentives
• Exemption from Import Duty on Raw Materials/Components
• Exemption from Import Duty and Sales Tax on Machinery/Equipment, Spare Parts and Consumables
For further information on incentivesfor investment, visitwww.mida.gov.my
REGULATORY CONTROL INTHE PHARMACEUTICAL INDUSTRY
21
22
Regulatory Agency
National Pharmaceutical Control Bureau (NPCB)
The regulatory control of pharmaceutical products and traditional medicines inMalaysia is carried out by the National Pharmaceutical Control Bureau (NPCB),an institution under the Pharmaceutical Services Division (PSD) Ministry ofHealth, which ensures the qual i ty, eff icacy and safety of pharmaceuticalproducts as wel l as the qual i ty and safety of tradit ional medicines andcosmetics marketed in the country.
The NPCB, formerly known as the National Pharmaceutical Control Laboratory,was set up in October 1978 to implement quality control on pharmaceuticalproducts. The infrastructure and faci l i t ies were designed to meet therequirements for testing and quality control activities.
The NPCB has in place a well-structured and comprehensive regulatory system.This system handles the registration of pharmaceutical products and traditionalmedicines as well as the notification of cosmetic products under the Control ofDrug and Cosmetics Regulations 1984.
The introduction of these regulations in June 1984 was an important milestonein the history of drug regulatory activit ies in Malaysia as it provides for theestabl ishment of the Drug Control Author i ty (DCA) to regulate thepharmaceutical industry. The DCA, an executive committee which is responsiblefor product registrat ion and l icensing of manufacturers, importers andwholesalers was establ ished in 1985, whereby the NPCB functions as theoperational arm and the secretariat to the DCA.
Regulatory Control in Pharmaceutical Industry
Regulatory Control in Pharmaceutical Industry 23
Since 1985, the NPCB has been given the task of ensuring the quality, efficacyand safety of pharmaceuticals through the registration and licensing scheme.This is achieved through evaluation of scientific data and laboratory tests on allproducts before they are marketed. A system to monitor products in the marketwas also setup. In addit ion, the Adverse Drug Reactions (ADR) monitoringprogram was launched in Malaysia in 1987 to carry out pharmacovigi lanceactivities. Under the surveil lance program, registered products are routinelysampled to ensure compliance with regulatory requirements.
Under the ASEAN Technical Co-operation among Developing Countries (ASEANTCDC) Program, the NPCB has been chosen and recognised by the ASEANcountries as the regional training centre for quality control of pharmaceuticals. NPCBhas been the host for various training programs in quality control and hassuccessfully conducted such trainings since 1986. In addition, the NPCB has alsobeen receiving trainees from ASEAN countries as well as various other countries.
In view of the technical expertise and training capabilities of NPCB, it receivedthe recognition as a "WHO Collaborating Centre in the Regulatory Control ofPharmaceuticals" on 10th May 1996. As a WHO Col laborat ing Centre forRegulatory Control of Pharmaceuticals, the NPCB wil l continue to providetraining in pharmaceutical quality assurance and regulatory affairs to fellowsfrom other countr ies. Due to its commitment and technical expert ise, thisinstitution is redesigned as WHO collaborating centre effective 1st August 2011for a period of 4 years.
In Addition, the NPCB successfully gained accession as the 26th member ofthe Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January2002. Since then, NPCB has been activety involved in International GoodManufacturing Practice (GMP) and Quality Assurance programmes.
Drug Control Authority (DCA)
The Drug Control Authority (DCA) is the executive body established under theControl of Drugs and Cosmetics Regulat ions 1984. The main task of thisAuthority is to ensure the safety, qual i ty and eff icacy of pharmaceuticals,traditional medicines, health supplements, veterinary products and personalcare products that are marketed in Malaysia.
This objective is being achieved through the following:
• Registrat ion of pharmaceutical products, natural products ( tradit ionalmedicines) and veterinary products
• Licensing of premises for importers, manufacturers and wholesalers
• Monitoring the quality of registered products in the market
• Adverse Drug Reaction Monitoring
NATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH MALAYSIA
CENTRE FORCOMPLIANCE &
LICENSING
GMP Section(Pharmaceutical)
GMP Section(Complementary)
Licensing andCerti�cation Section
Quality and IndustrialDevelopment Section
GDP Section
CENTRE FORQUALITY CONTROL
Bio-PharmaceuticalTesting Section
LaboratoryServices Section
Standards andQuality Section
Natural ProductsTesting Section
PharmaceuticalChemistry Testing
Section
Research andDevelopment
Section
VariationsSection
CENTRE FORADMINISTRATION
Finance Unit
Development Unit
Administration Unit
Asset Management/Store Unit
CENTRE FOR PRODUCTREGISTRATION
TherapeuticMedical Section
VeterinaryMedicine Section
Active PharmaceuticalIngredient (API)
Section
RegulatoryCoordination Section
Biologics andComplementary
Section
CENTRE FORPOST REGISTRATION
PharmacovigilanceSection
Surveilance andProduct Complaints
Section
CosmeticsSection
CENTRE FORORGANISATIONAL
DEVELOPMENT
InformationCommunication
Technology Section
Interrelations andPolicy Section
GCP CompianceSection
GLP ComplianceSection
Human Resource andQuality Coordination
Section
CENTRE FORINVESTIGATIONAL
NEW PRODUCT
InvestigationalProduct Evaluation
Section
InvestigationalProduct Safety
Monitoring Section
DIRECTOR OF REGULATORY PHARMACY
MINISTRTIONAL PHA NAATIONAL PHARMACEUTICAL CONTROL BUREAU
YTH MALA AYSIAY OF HEAL LTH MALAMINISTRTIONAL PHARMACEUTICAL CONTROL BUREAU
YSIATIONAL PHARMACEUTICAL CONTROL BUREAU
REGISTRACENTRE FOR PRODUCT
Therapeutic
TIONSTRAATIONCENTRE FOR PRODUCT
Therapeutic
DIRECTOR OF REGULA
TIONPOST REGISTRA ATIONCENTRE FOR
Pharmacovigilance
Y PHARMACYTOR OF REGULA ATOR
LICENSINGCOMPLIANCE &
CENTRE FOR
GMP Section
Y PHARMACY
LICENSINGCOMPLIANCE &
CENTRE FOR
GMP SectionMedical Section
Medicine Section eteVVe
Sectionedient (API)Ingr
Active Pharmaceutical
Medical SectionTherapeutic
Medicine Section eterinary
Sectionedient (API)
Active Pharmaceutical
SectionPharmacovigilance
Sectionoduct ComplaintsPrSurveilance and
SectionCosmetics
(Pharmaceutical)GMP Section
(Complementary)GMP Section
Certi�cation SectionLicensing and
(Pharmaceutical)GMP Section
(Complementary)GMP Section
Certi�cation SectionLicensing and
QUALITY CONTROLCENTRE FOR
dination SectionCoorRegulatory
SectionComplementaryBiologics and
QUALITY CONTROLCENTRE FOR
dination SectionRegulatory
SectionComplementaryBiologics and
SectionariationsVVariations
DEVELOPMENTTIONALORGANISAATIONAL
CENTRE FOR
echnology SectionTTechnology SectionCommunication
Information
Development SectionQuality and Industrial
GDP Section
TADMINISTRAATIONCENTRE FOR
Development SectionQuality and Industrial
GDP Section
TIONCENTRE FOR
QUALITY CONTROL
esting TTesting SectionBio-Pharmaceutical
esting TTesting SectionNatural Pr
Pharmaceutical
QUALITY CONTROL
esting SectionBio-Pharmaceutical
esting SectionoductsNatural Pr
Pharmaceutical
echnology Section
Policy Sectionelations andInterr
SectiondinationQuality Coor
ce andHuman Resour
CENTRE FOR
TADMINISTRAATION
Finance Unit
Development Unit
TION
Finance Unit
Development Unit
Services SectionLaboratory
SectionChemistry T
SectionDevelopmentResear
Services SectionLaboratory
Sectionestingstry T Testing
SectionDevelopment
ch andResear
NEW PRODUCTTIONALINVESTIGAATIONAL
Sectionoduct EvaluationPrInvestigational
Monitoring Sectionoduct SafetyPr
Investigational
Administration Unit
e UnitStorAsset Management/
Administration Unit
Asset Management/
Quality SectionStandarQuality Section
ds andStandarSection
GCP Compiance
SectionGLP Compliance
24 Regulatory Control in Pharmaceutical Industry
Regulatory Control in Pharmaceutical Industry 25
Product Registration
Introduction
The guidelines outlined in the Drug Registration Guidance Document (DRGD)primarily drawn up in accordance with the legal requirements of the Sale ofDrugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.Although the legal requirements of other related legis lat ions have beenincluded, applicants are reminded that it is their responsibility to ensure thattheir products comply with the requirements of these legislations, namely:
• Dangerous Drugs Act 1952;
• Poisons Act 1952;
• Medicine (Advertisement & Sale) Act 1956;
• Patent Act 1983; and
• any other relevant Acts.
Definition of a Product
Under the Control of Drugs and Cosmetics Regulations 1984, a ‘product’ asdefined in the Regulations, means a ‘drug’ in a dosage unit or otherwise, foruse wholly or mainly by being administered to one or more human beings oranimals for a medicinal purpose. Under the Sale of Drugs Act 1952, ‘drug’includes any substance, product or article intended to be used or capable, orpurported or claimed to be capable of being used on humans or any animal,whether internally or externally for a medicinal purpose used in humans (andanimals).
Drug Registration
• Regu la t ion 7 (1 ) (a ) o f the Cont ro l o f Drugs and Cosmet ics 1984(Amendment 2006) requires al l products to be registered with the DCAprior to being manufactured, sold, supplied, imported or prossessed oradministered, unless the product is exempted under specif ic provision ofthe Regulations.
• Any drug in a pharmaceut ica l dosage fo rm in tended to be used, o rcapable or purported or claimed to be capable of being used on humansor any animals, whether internal ly or external ly for a medical purposes isrequired to be registered with the DCA.
26 Regulatory Control in Pharmaceutical Industry
• Medicinal purpose means any of the following purposes:
- Al leviat ing, treat ing, cur ing or prevent ing a disease or a pathological condition, or symptoms of a disease
- Diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological condition;
- Contraception;
- Inducing anaesthesia;
- Maintaining, modifying, preventing, restoring or interfering with, the normal operation of a physiological function;
- Controlling body weight;
- General maintenance or promotion of health or well-being
• The Regulations do not apply to the following products:
- Diagnostic agents and test kits for laboratory use;
- Medical devices:
i. Non-medical medic and contraceptive devices;
ii. Non-medical bandages, surgical dressing, plaster, dental fillings;
iii. Instruments apparatus, syringes, needles, sutures, catheters;
- Food, (as def ined under Food Act 1983 and Food Regulat ions 1985, includes every article manufactured, sold or represented for use as food or dr ink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specif ic disease, disorder or medical condit ion, and food which contain quantities of added nutrients allowable under the Food Act and Regulations).
- Cosmetics, (in conformance with the harmonisation of cosmetic regulationsin the ASEAN region and in compliance to the ASEAN Cosmetic Directive, cosmetics are regulated via the notif ication process starting 1 January 2008).
• Products which are not registered with the DCA and are intended to be imported for the purpose of cl inical tr ial shal l have a Clinical Trial Import Licence (CTIL).
• Products which are not registered with the DCA and are intended to bemanufactured local ly for the purpose of cl in ical tr ia l should apply forexemption by the DCA (Cl in ical Tr ia l Exemption) from Director ofPharmaceutical Services.
• Any person who wishes to manufacture any product solely for the purpose ofproducing a sample for the sole purpose of registration should apply for anexemption for manufacture of sample (Appl ies to local ly manufacturedproducts only).
Regulatory Control in Pharmaceutical Industry 27
Application TypeApplication for a new product registration may be categorised as follows:
i. Application for an innovator product (NCE/Biotech)
ii. Application for a generic product (Controlled Poisons & Non-Controlled Poisons)
[a generic product is a product that is essentially similar to a currently
registered product in Malaysia. The term generic is not applicable to
biological and biotech products]
iii. Application for product registration via the abridged procedure (for
certain categories of OTC products and traditional medicines)
A
Data Requirements
The data required to support an application is divided into:
i. Administrative data (Part I)
ii. Data to support product quality (Part II)
iii.Data to support product safety (Part III)
iv. Data to support product efficacy (Part IV)
Applicants are advised to read the explanatory notes in Section 2 of Drug Registration Guidance Document, and also the relevant ASEAN or ICH Guidelines (www.ich.org) and checklists, for full information on product data requirement. The DCA may request for supplementary information.
B
Data Submission
Data to be submitted will be based on the application type:
i. Innovator product – Parts I to IV (For existing chemical or biological entity(s) in a new dosage form, only Parts I and II, together with pharmacokinetic data will be required)
ii. Generic product – Parts I & II onlyiii. Abridged procedure – Part I only
The applicant should make available the requested information within
the specified period. Failure to do so may result in the rejection
of the application.
C
New Application Processing Procedures
28 Regulatory Control in Pharmaceutical Industry
Application Formalities
The DCA only accepts applications which are being submitted through web-based online system at http://www.bpfk.gov.my. The applicant for productregistration must be registered with Malaysian Registrar of Business (ROB) orCompanies Commission of Malaysia (SSM). The applicant, (if the said companyis not the product owner) should be authorised in writing by the product ownerto be the holder of the product registration certificate and be responsible forall matters pertaining to the registration of the product.
a. Responsibility of Marketing Authorisation Holder (i.e. the applicant for product registration)
• The applicant shall be responsible for the product and all information supplied in support of his application. He shall be responsible for updating any information relevant to the product/application during the course of evaluation and after product registration.
• Any person who knowingly supplies any false or misleading information in connection with his application commits an offence under the Control of Drugs and Cosmetics Regulations 1984.The applicant is responsible for the quality, safety and efficacy of his products.
Regulatory Control in Pharmaceutical Industry 29
b. Application Fee
Every application for registration shall incur a processing fee:
* The DCA will charge the applicant such costs as it may incur for the purpose of carrying outlaboratory investigation relating to the registration of any product. (Any payment made is notrefundable once an application has been submitted and payment confirmed)
Product Category Processing Fee Laboratory Fee *
Traditional Product/ Traditional RM500 RM700 for
Health Supplement (each product) laboratory tests
Pharmaceutical Product/ RM1,000 RM1,200
Pharmaceutical Health (1 active ingredient) or
Supplement RM2,000
(2 or more active
ingredient) as fee for
analytical validation
evaluation method
New Chemical Entities/Biotech RM1,000 RM3,000
(1 active ingredient) or
RM4,000
(2 or more active
ingredient) as fee for
analytical validation
evaluation method
Veterinary Product RM1,500 Not applicable
(each poison /
OTC product, inclusive
of laboratory tests)
RM1,200
(each natural product,
inclusive of laboratory
tests)
Cosmetic Product RM50 Not applicable
(each product)
30 Regulatory Control in Pharmaceutical Industry
c. Accompanying Documents
i) The following documents are to be submitted together with the application:
• Authorisation from the product owner
• Letters of authorisation of contract manufacture and acceptance as wellas from the manufacturer and also each sub-contractor, where a product is contract manufactured, if applicable (e.g. repacker).
ii) The letter of authorisation or acceptance from the manufacturer should beon the product owner’s original letterhead and be dated and signed by theManaging Director, President, CEO or an equivalent person who has overallresponsibility for the company or organisation
iii) The letters should state the name of the product concerned, name andactual plant address of the manufacturer(s) involved in the manufacture ofthe product.
iv) Imported products will also need to be accompanied with either:
• Certificate of Pharmaceutical Product (CPP) from the competent authorityin the country of origin; OR
• Certification for Free Sales (CFS) and Good Manufacturing Practice (GMP)from the relevant authorit ies for tradit ional medicines and dietarysupplements
For more information, please referto the ‘Drug Registration GuidanceDocument’ in the NPCB’s websiteat www.bpfk.gov.my
Regulatory Control in Pharmaceutical Industry 31
Application Process
a. Initiation of Review
Review of appl icat ions wi l l fol low a queue system. There wi l l be separatequeues for the different categories of products:
• New Chemical Entity (NCE)
• Biotech
• Generics (full evaluation procedure)
• Abridged Evaluation Procedure Pharmaceuticals (OTC)
• Traditional Products
b. Time Frame
The time frame for registration of products:
• The t ime frame for each product is calculated from the date of f inal andcomplete submission.
• Priority review may be granted where the product is intended for treatmentof a ser ious or l i fe-threatening disease (where the l ikel ihood of death is high unless the course of the disease is interrupted).
Full Evaluation Timeline
Prescription Drugs (Poison) 210 working days
Non-prescription (Non-poison) Drugs 210 working days
NCE 245 working days
Abridged Evaluation Timeline
Health Supplement Products
Natural Products (Traditional)
Cosmetic Products (Notification Note)
- Single active ingredient: 60 working days
- 2 or more active ingredients:80 working days
32 Regulatory Control in Pharmaceutical Industry
Regulatory Outcome
a. Decisions of the DCA
An application may be approved or rejected and the DCA decision will be sentvia e-mail to the marketing authorisation holder.
b. Product Registration Number
• A Registration Number, which is specific for the product registered, will begiven via e-mail when an application is approved by the DCA. Registrationis valid for a period of 5 years.
• Product Notification Number will be given to a cosmetic product after thenotification process.
c. Rejection, Cancellation, Suspension of Registration
The DCA may reject, cancel or suspend the registrat ion of any product i fthere are deficiencies in safety, quality or efficacy of the product or failure tocomply with conditions of registration.
d. Appeal against DCA decisions
Any applicant aggrieved by the decisions of the DCA may make a written appealto the Minister of Health. Appeals MUST be made within fourteen days from thedate of the DCA notification. A period of 180 days from the date of appeal isgiven for submission of any support ing data or documents for NCE andbiotechnology products and 90 days for other products. The appeal is closedif all the required information is not submitted within the stated time given.
e. Decision of the Minister
The decision made on any appeal is final.
Regulatory Control in Pharmaceutical Industry 33
Registration Maintenance
a. Conditions for RegistrationThe affixing of the security device, one of the conditions for product registration,to product labelling has been identified as a means to verify and authenticatethat the product has been duly registered with the DCA.
The DCA may specify certain conditions for registration for a particular group,amend any condit ions for registrat ion and may lay down specif ic productlabelling requirements.
The DCA may cancel theregistrat ion of any product i fthe conditions for registrationare not complied with.
b. Validity Period
The registration of a product is valid for 5 years or such period as specified inthe registration certificate.
For cosmetic products, the Notification Note is valid for 2 years or such periodas specified in the Notification Note.
Renewal of product registration should be done six months prior to the expiryof the validity period of product registration. Upon expiry of the validity periodof registration, the module for renewal of product registration will no longerbe accessible and application for re-registration of the product can no longerbe submitted.
c. Change In Particulars of Registered Products
Changes in particulars of a Registered product require DCA approval. Changesrefer to any changes in product name, product specif icat ions, packing,indications, contents of product label, package insert, or product literature,or any relevant particulars of the registered product.
• Any changes in excipients, such as change in lubricant, preservative, solventin film coating, etc to improve product formulation requires prior approval ofthe DCA.
• Explanation/reason for the changes should be given. All relevant supportingdata related to the above changes should be updated accordingly.
• The registration of a product may be cancelled if changes are made withoutprior approval of the DCA.
For information on product conditionsfor reg is t ra t ion , p lease re fe r toAppendices 1, 1.1, 2 & 3 of the DrugRegistration Guidance Document fromwww.bpfk.gov.my.
34 Regulatory Control in Pharmaceutical Industry
• The market ing author isat ion holder mustensure that all the necessary validation hasbeen conducted to demonstrate that thechange does not reduce the quality, safety oreff icacy of the product and submit al lnecessary documents.
d. Reporting Problems with Registered Products
i. Adverse Drug Reactions (ADR)
• All market authorisation holders (MAH) must ensure that an appropriatesystem of pharmacovigilance is in place in the company order to accentresponsibility and liability for its products on the market and ensure thatappropriate action can be taken, when neccessary.
• MAH sould inform the pharmacovigi lance sect ion of Nat ionalPharmaceutical Control Bureau, in writ ing of al l matters pertaining tothe safety of the products.
• All report of adverse reaction associated in the use of registered productoccuring in Malaysia must be reported to the NPCB within the stimulatedtimeline.
• MAH who have registered a product containing new chemical entity mustroutinely submit periodic safety updates reports (PSUR) on that product6 monthly for the first 2 years after approved in Malaysia and annuallyfor the subsequent 3 years.
• All labels and package inserts must be amended to include any new ADR,warning, precautions, etc. within the time frame given by the DCA.
ii. Market Surveillance of Registered Products
• Samples of registered products may be tested for compl iance withstandards or specif icat ions and i f they fai l to meet adequatespecifications, the marketing authorisation holder will be issued a warningand has up to 30 days to identi fy the source of qual i ty defect(s) andactions taken to improve quality unless the failure is serious enough tojustify recall of the product.
iii. Product Complaints
• The market authorisation holder should notify the DCA of any productquality related problems that the holder is aware of.
• Complaints submitted to the DCA by health care professionals,consumers, and patients will be investigated. Based on the outcome ofthese investigations, appropriate action will be taken which may includeproduct/batch recalls, cancellation/suspension of product registrationsor other regulatory action as deemed necessary.
F o r m o re i n f o r m a t i o n ,please refer to Appendix 4o f D r u g R e g i s t r a t i o nGuidance Document fromwww.bpfk.gov.my
Regulatory Control in Pharmaceutical Industry 35
iv. Product Recalls
• The decision for recall shall be made when there is or may cause potentialrisk to the user of the products. Recall may be done voluntanly by theproduct registrat ion holder or directed by the Senior Director ofPharmaceutical Services, Ministry of Health Malaysia.
• The product registration holder is responsible for conducting recalls ofdefect or unsafe product. No recal l should take place without f i rstconsulting or informing the Senior Director of Pharmaceutical Services.
e. Termination of Registration by Marketing Authorisation Holder
The marketing authorisation holder shall inform the DCA of decision to terminatethe registration of a product before the end of the validity of such registrationand surrender the product registration certificate immediately to the DCA.
f. Change in Manufacturing Site
• Applies to change of manufacturing site for part or all of the manufacturingprocess of the product but does not cover changes related to a new sitewhere only batch release takes place or to a new packager as these changesare covered under appl icat ions for amendments to the part iculars of aregistered product (variation).
• The new manufactur ing site should comply with the current GoodManufacturing Practice (GMP). Local manufacturing sites are subjected topre-licensing inspections and for sites outside Malaysia, certification by acompetent authority is sufficient. However, the DCA reserves the right toconduct an inspection on any manufacturing site.
• This procedure is applicable for:
- Change in the manufactur ing site for the same company, including rationalisation in the event of mergers; and
- Where a company which previously contracts out the manufacture of its product transfers the manufacture to its own premises
• A change in manufactur ing site between contract manufacturers is not routinely allowed but may be considered in a crisis situation.
• There are 5 different types of site change, hence require different sets ofaccompanying documents.
36 Regulatory Control in Pharmaceutical Industry
Type I : Change of Manufacturing Site Within Malaysia
Type II : Change of Manufacturing Site from ForeignCountry to Malaysia
Type III : Change to Manufacturing Site Located OutsideMalaysia
Type IV : Change o f Manufactur ing S i te for Spec ia lCategory Products
Type V : Crisis Situation
g. Other Information
i) Products for Export Only
• The DCA may register the following locally manufactured products forexport only:
- Product(s) registered by the DCA but sold in a di fferent colour (formulation), shape and strength;
- Products which contain ingredients not allowed by the DCA for local use (terms and conditions apply), provided that confirmation in writing is obtained from the competent authority of the importing country that there is no objection to the importation and sale of the formulation in quest ion. Evidence of registrat ion of sol id formulat ion with the competent author i ty in import ing country may be accepted as supporting data.
• If there is no change in the formulation or appearance of the product,registration for export purposes is not necessary.
• An “export notification” procedure allows an applicant to apply for FreeSale Certif ication (CFS) of the product whereby the applicant need todeclare to the DCA the differences in the product for export comparedto the registered product marketed in Malaysia.
• A Certificate of Pharmaceutical Product will be issued to the applicant forthe registered product.
For the description of each category, please refer to DrugRegistration Guidance Document in the NPCB website atwww.bpfk.gov.my
Regulatory Control in Pharmaceutical Industry 37
ii) Combination Packs
• Products which are packed together in combination for a therapeuticregimen can be registered as a single product.
• Where the combinat ion pack product consists of registered andunregistered products, the unregistered product needs to be registeredbefore submitting the registration application for the combination pack.
• Where the combination pack consists of registered products which aresourced from different product owners, letters of authorisation from theproduct owners shall be submitted, together with the following productdetails :-
- Product Name;
- Product Registration Number.
iii) Use of HALAL logo
The use of HALAL logo on the labels of pharmaceutical products wil l notbe al lowed except for t radit ional products, dietary supplements anda lso cosmetics providedthat such products havebeen cert i f ied andapproved as HALAL byDepartment of Is lamicDevelopment Malaysia(JAKIM)
iv) Product Labelling, Bioequivalence, New/Additional IndicationPlease refer to the Drug Registration Guidance Document in NPCB website
for details.
For details, please visit the HalalIndustry Development Corporationwebsite at www.halal.gov.my
38 Regulatory Control in Pharmaceutical Industry
Online Registration System
Quest is an online submission system for the product licence holder to conductsecured online transactions on registration, change request, market sampling,renewal and other transactions
Note:The public can access the product search on both QUEST 2 and QUEST 3 tosearch for registered products, product registration holders as well as productmanufacturers.
Quest 3 Customer Support Number
603-7883 5400 extension: 5560/ 5561/ 5562
USB Token System Customer Service Department
Tel: 603-8992 8888URL: http://www.digicert.com.myE-mail:[email protected]
Payment received by Digicert
Evaluation of applicationby BPFK Officer
Send payment+ slip asadviced in the slip (toDigicert Sdn. Bhd.)
Pin number will be send
separately via POSLAJU
USB Token will be sentwithin 7 working daysby Digicert Sdn. Bhd.
via POSLAJU
Password will beemailed to the emailaddress specified in
the application
Regulatory Control in Pharmaceutical Industry 39
USB TOKEN/MEMBERSHIP APPLICATION FOR FIRST TIME USER
www.bpfk.gov.my
First time user registration
Applicant mustremember the
chosenUsername
Membership registration form
Fill in company and membership details (All fields are compulsory)
Scan and attach documents: 1. Company Registration Form 2. Company Authorisation Letter 3. Identity Card (Front Only)
Submit application
Login to QUEST3 and proceed with Product Registration/Cosmetic Notification
Print membership slip
Print membership slip
Correspondence through email
Quest 3
Application rejected Satisfactory
Not satisfactory
Res
ub
mit
ap
plic
atio
n
No response
40 Regulatory Control in Pharmaceutical Industry
Licence Issued for Registered Products
NPCB processes the application and issues the following licences:
• Manufacturer’s Licence (Form BPFK-426.3_LK)
• Importer’s Licence (Form BPFK-424.3_LI)
• Wholesaler’s Licence (Form BPFK-422.3_LB)
Licensing FeesThe licensing fees for the application for the various licences are as follows:
Licence ApplicationThe Application for the above licences can be submitted manually or onlinethrough the NPCB QUEST 3 Online Submission System. Application forms mustbe accompanied with the following documents:
i) New Application:
• Organisation chart of the company (including names of the staff)
• Premises location plan (A4 size)
• Floor plan for premises (A4 size)
• List of storage, manufacturing and quality control facilities
• Products recall procedure
• List of other products (non-registered products) stored in the same premises
• Copy of Registration of Company (ROC) or Registration of Business (ROB) certificate
• Copy of Business Licence (Issued by the State Local Authority)
• Copy of identity card of applicant/licence holder
• Copy of Retention of Pharmacist Certificate*
• Copy of Annual Registration Certificate*
• Copy of Type A Licence*
Licence Registration Fee Timeline Validity Renew Before
Manufacturer’s Licence RM 1000 10 working days 1 year December
Importer’s Licence RM 500 10 working days 1 year December
Wholesaler’s Licence RM 500 10 working days 1 year June
ii) Application Renewal:
• Copy of Business Licence (Issued by the State Local Authority)
• Copy of identity card of applicant/licence holder
• Copy of Type A Licence*
• Copy of previous licence
*Note: If applicant is a registered pharmacist
Regulatory Control in Pharmaceutical Industry 41
Application forms for Manufacturer’sLicence, Importer’s Licence andWholesaler’s Licence can bedownloaded from NPCB’s website atwww.bpfk.gov.my
Manufacturer’s Licence Application Procedures
The layout plan must be submitted to the Centre for Compliance and Licensingof National Pharmaceutical Control Bureau for evaluation. At the same time, anapplicant may register the company with SSM.
The layout plan and design shall fulfil the following:
• Premise should be of suitable size, design, construction and its location.
• Have sufficient working area for the placement of equipment or machines andother materials for operational purposes.
• Able to avoid cross over between material flow personnel flow, and storageof materials.
• Once the plan has been approved, applicant shall seek additional advice/approval from the Fire Department and Department of Environmental prior toconstruction.
• Applicant shall prepare a complete documentation system that comprisesof directions, explanations, specif ications and records pertaining to theoperation.
• Once the construction of manufacturing facilities is completed, the applicantshall seek an appointment with the GMP auditor to inspect the premise forpre-licensing purpose.
• Applicant may also apply for Business Licence from local state authority.
• The report of the findings will be delivered 14 working days after the date ofinspection and Letter of Confirmation (LOC) will be issued by the Centre forCompliance and Licensing once approved.
• During product registration, if the Centre for Product Registration requiressamples for testing purposes, applicant may write an official letter to permitthe manufacturing of that particular product.
• Once product has been registered, applicant may apply for manufacturer’slicence.
• Appl icat ion wi l l only be processed once payment has been made to theCentre for Administration.
• Once approved, the manufacturer’s l icence can be collected from Centrefor Compl iance And Licensing or i t wi l l be posted to the manufactur ingaddress.
42 Regulatory Control in Pharmaceutical Industry
Regulatory Control in Pharmaceutical Industry 43
Application Process to Obtain Manufacturing Licence
Corrective Action
Floor plan does notcomply with
GMP requirement
Premise does notcomply with
GMP requirement
Send Floor Plan to CGMP for Evaluation
Floor Plan Approved
Invite GMP Auditor to PerformPre-licensing InspectionCorrective Action
Premise Approved
Issuance of Letter of Confirmation (LOC)
Product Registration Process
Registration Number Confirmed(MAL Number)
Application for Manufacturer’s Licence
Manufacturer’s Licence Issued
44 Regulatory Control in Pharmaceutical Industry
Bioavailability and Bioequivalence Study forPharmaceutical Products
IntroductionBioavai labi l i ty (BA) test ing of drug products in humans provides the mostappropriate method available for determining bioequivalence. Demonstrationof bioequivalence (BE) is general ly the most appropriate method ofsubstantiating therapeutic equivalence between medicinal products.
Bioavailability:Bioavailabi l i ty means the rate and extent to which the active substance ortherapeutic moiety is absorbed from a pharmaceutical form and becomesavailable at the site of action.
Bioequivalence:Two medicinal products are bioequivalent if they are pharmaceutical equivalentsor alternatives and if their bioavailabilities (rate and extent) after administrationin the same molar dose are similar to such degree that their effects, with respectto both efficacy and safety, will be essentially the same.
Effective 1st January 2012, the DCA had imposed on Bioequivalence (BE)studies requirement for all immediate releases oral, solid dosage form genericproducts containing scheduled poison as Act ive Ingredients as wel l asaccreditation of BE research centres.
Generic Product List and Guidelines for BioequivalanceStudiesA list of drug substances which, when formulated in oral solid dosage forms,require BE data as a prerequisite for registration, has been established by theDCA. The l ist and guidel ines can be found in the NPCB website atwww.bpfk.gov.my .
USEFUL CONTACTS
45
46 Useful Contacts
MALAYSIAN INVESTMENT DEVELOPMENT AUTHORITY (MIDA)
MIDA SentralNo. 5, Jalan Stesen Sentral 5Kuala Lumpur Sentral50470 Kuala Lumpur, MalaysiaTel: (603) 2267 3633 Fax: (603) 2274 7970E-mail: [email protected]: www.mida.gov.my
ASIA-PACIFIC
AUSTRALIAConsul-Investment/DirectorConsulate of MalaysiaMalaysian InvestmentDevelopment AuthorityLevel 6, MAS Building16 Spring StreetSydney, NSW 2000, AustraliaTel: (612) 9251 1933 Fax: (612) 9251 4333E-mail: [email protected]
JAPANTokyoDirectorMalaysian InvestmentDevelopment Authority32F, Shiroyama Trust Tower4-3-1, Toranomon, Minato-kuTokyo 105-6032, JapanTel: (813) 5777 8808Fax: (813) 5777 8809E-mail: [email protected]: www.midajapan.or.jp
OsakaDirectorMalaysian InvestmentDevelopment AuthorityMainichi Intecio 18F3-4-5 Umeda, Kita-kuOsaka 530-0001, JapanTel: (816) 6451 6661Fax: (816) 6451 6626E-mail: [email protected]
PEOPLE’S REPUBLIC OFCHINAShanghaiConsul (Investment)Consulate General of Malaysia(Investment Section)Malaysian InvestmentDevelopment AuthorityUnits 807-809, Level 8Shanghai Kerry CentreNo. 1515, Nanjing Road (West)Shanghai, 200040People’s Republic of China Tel: (8621) 6289 4547/5298
6335Fax: (8621) 6279 4009E-mail: [email protected]
GuangzhouDirectorMalaysian InvestmentDevelopment AuthorityUnit 1804B-05CITIC Plaza Office Tower233 Tianhe Be RoadGuangzhou, 510610People’s Republic of ChinaTel: (8620) 8752 0739Fax: (8620) 8752 0753E-mail: [email protected]
TAIWANDirector (Investment Section)Malaysian Friendship & TradeCentreMalaysian InvestmentDevelopment Authority12F Suite A, Hung Kuo BuildingNo. 167, Tun Hua North RoadTaipei 105, TaiwanTel: (8862) 2713 5020/
2718 6094Fax: (8862) 2514 7581E-mail: [email protected]
KOREA, REPUBLIC OFCounsellor (Investment)Embassy of Malaysia (Investment Section)Malaysian InvestmentDevelopment Authority17th Floor, SC First Bank Building100, Gongpyung-dong, Jongro-guSeoul 110-702, Republic of Korea Tel: (822) 733 6130/6131Fax: (822) 733 6132E-mail: [email protected]
UNITED ARAB EMIRATESDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia(Investment Section)Unit 2205, 22nd Floor, Tower ABusiness Central Tower, DubaiMedia City(P.O. Box: 502876) DubaiUnited Arab EmiratesTel: (9714) 4343 696/697Fax: (9714) 4343 698E-mail: [email protected]
INDIADirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia (Investment Section)81 & 87, 8th Floor, 3rd NorthAvenue Marker MaxityBandra Kurla Complex,Bandra (E)Mumbai 400051, IndiaTel: (9122) 2659 1155/1156Fax: (9122) 2659 1154E-mail: [email protected]
SINGAPOREDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityNo. 7, Temasek Boulevard 26-01, Suntec Tower One Singapore 038987 Tel: (65) 6835 9326/
9580/7069Fax: (65) 6835 7926E-mail: [email protected]
THAILANDDirector/Investment CounsellorMalaysian InvestmentDevelopment Authority3601, 36th Floor, Q. HouseLumpini Building South Sathorn Road Tungmahamek, Sathorn Bangkok 10120, ThailandTel: (66) 2677 7487Fax: (66) 2677 7488E-mail:[email protected]
MIDA’S OVERSEAS OFFICES
Useful Contacts 47
EUROPE
SWEDENEconomic CounsellorEmbassy of MalaysiaKarlavägen 37, P.O. Box 26053S-10041 Stockholm, SwedenTel: (468) 791 7942/
440 8400Fax: (468) 791 8761E-mail: [email protected]
UNITED KINGDOMDirectorMalaysian InvestmentDevelopment Authority17 Curzon StreetLondon W1J 5HR, United KingdomTel: (4420) 7493 0616Fax: (4420) 7493 8804E-mail:[email protected]
GERMANY, FEDERALREPUBLIC OFFrankfurtDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia(Investment Section)17th Floor, Frankfurt KastorPlatz der Einheit 160327 Frankfurt am Main,GermanyTel: (4969) 7680 7080Fax: (4969) 7680 708-20E-mail: [email protected]
MunichDirectorMalaysian InvestmentDevelopment Authority6th Floor, BurkleinhausBurkleinstrasse 1080538 Munich, GermanyTel: (4989) 2030 0430Fax: (4989) 2030 4315E-mail: [email protected]
FRANCEDirectorMalaysian InvestmentDevelopment Authority42, Avenue Kleber75116 Paris, FranceTel: (331) 4727 3689/6696Fax: (331) 4755 6375E-mail: [email protected]
ITALYConsul-InvestmentConsulate of Malaysia(Investment Section)Malaysian InvestmentDevelopment Authority5th Floor, Piazza Missori 320123 Milan (MI), ItalyTel: (3902) 3046 521Fax: (3902) 3046 5242E-mail: [email protected]
NORTH AMERICA
LOS ANGELESConsul (Investment)Consulate General of Malaysia(Investment Section)550, South Hope Street, Suite 400Los Angeles, California 90071United States of AmericaTel: (1213) 955 9183/
9877Fax: (1213) 955 9878E-mail: [email protected]
SAN JOSEMalaysian InvestmentDevelopment Authority226, Airport Parkway, Suite 480San Jose, California 95110United States of AmericaTel: (1408) 392 0617/8Fax: (1408) 392 0619E-mail: [email protected]
NEW YORKConsul (Investment)Consulate General of Malaysia(Investment Section)313 East, 43rd Street, NewYorkNew York 10017United States of AmericaTel: (1212) 687 2491Fax: (1212) 490 8450E-mail: [email protected]
BOSTONDirectorMalaysian InvestmentDevelopment AuthorityOne International Place, Floor 8Boston, MA 02110United States of America Tel: (1617) 338 1128/
338 1129Fax: (1617) 338 6667E-mail: [email protected]
CHICAGODirectorMalaysian InvestmentDevelopment AuthorityJohn Hancock Center, Suite 1515875, North Michigan AvenueChicago, Illinois 60611United States of AmericaTel: (1312) 787 4532Fax: (1312) 787 4769E-mail: [email protected]
HOUSTONDirectorMalaysian InvestmentDevelopment Authority6th Floor, Suite 630 Lakes on Post Oak 3050 Post Oak Boulevard Houston, TX 77056 United States of AmericaTel: (1713) 979 5170 Fax: (1713) 979 5177/78E-mail: [email protected]
AFRICA
JOHANNESBURG
REPUBLIC OF SOUTH AFRICAEconomic CounsellorHigh Commission of MalaysiaGround Floor, Building 5Commerce Square Office Park39 Rivonia Road, SandhurstSandton, JohannesburgRepublic of South AfricaTel: (2711) 268 2307/
268 2314Fax: (2711) 268 2204E-mail: [email protected]
48 Useful Contacts
KEDAH & PERLISDirectorMalaysian Investment DevelopmentAuthorityLevel 4, East Wing, No. 88Menara Bina Darulaman BerhadLebuhraya Darulaman05100 Alor Setar Kedah Darul AmanMalaysia Tel: (604) 731 3978Fax: (604) 731 2439Email: [email protected]
PENANGDirectorMalaysian Investment DevelopmentAuthority4.03, 4th FloorMenara Boustead Penang39, Jalan Sultan Ahmad Shah10050 Pulau Pinang Malaysia Tel: (604) 228 0575Fax: (604) 228 0327E-mail: [email protected]
PERAKDirectorMalaysian Investment DevelopmentAuthority4th FloorPerak Techno Trade Centre (PTTC)Bandar Meru RayaOff Jalan JelapangP.O. Box 210, 30720 IpohPerak Darul RidzuanMalaysia Tel: (605) 5269 962 / 961Fax: (605) 5279 960E-mail: [email protected]
MELAKADirectorMalaysian Investment DevelopmentAuthority3rd Floor, Menara MITCKompleks MITCJalan Konvensyen75450 Ayer Keroh MelakaMalaysia Tel: (606) 232 2876/78Fax: (606) 232 2875E-mail: [email protected]
NEGERI SEMBILANDirectorMalaysian Investment DevelopmentAuthority Suite 13.01 & 13.0213th Floor, Menara MAA70200 SerembanNegeri SembilanMalaysiaTel: (606) 762 7921/7884Fax: (606) 762 7879E-mail: [email protected]
JOHORDirectorMalaysian Investment DevelopmentAuthorityNo.5, Level 13Menara Tabung HajiJalan Ayer Molek80000 Johor Bahru, Johor MalaysiaTel: (607) 224 2550/ 5500Fax: (607) 224 2360E-mail: [email protected]
PAHANGDirector Malaysian Investment DevelopmentAuthoritySuite 3, 11th FloorKompleks TeruntumP.O.Box 178,25720 Kuantan, Pahang MalaysiaTel: (609) 513 7334Fax: (609) 513 7333E-mail: [email protected]
KELANTANDirector Malaysian Investment DevelopmentAuthorityAras 5-CMenara Pejabat KelantanTrade CentreJalan Bayam15200 Kota Bharu, Kelantan MalaysiaTel: (609) 748 3151Fax: (609) 744 7294E-mail: [email protected]
SELANGORDirector Malaysian Investment DevelopmentAuthority 22nd Floor, Wisma MBSAPersiaran Perbandaran40000 Shah AlamSelangor Darul EhsanMalaysiaTel: (603) 5518 4260Fax: (603) 5513 5392E-mail: [email protected]
TERENGGANUDirectorMalaysian Investment DevelopmentAuthority5th Floor, Menara Yayasan IslamTerengganuJalan Sultan Omar20300 Kuala Terengganu, TerengganuMalaysiaTel: (609) 622 7200Fax: (609) 623 2260E-mail: [email protected]
SABAHDirectorMalaysian Investment DevelopmentAuthorityLot D9.4 & D9.5, Tingkat 9 Block D, Bangunan KWSPKaramunsing 88100 Kota Kinabalu SabahTel: (6088) 211 411Fax: (6088) 211 412Email: [email protected]
SARAWAKDirectorMalaysian Investment DevelopmentAuthority Room 404, 4th FloorBangunan Bank NegaraNo.147, Jalan Satok, P.O.Box 71693714 KuchingSarawakMalaysiaTel: (6082) 254 251/237 484Fax: (6082) 252 375E-mail: [email protected]
MIDA STATE OFFICES
Useful Contacts 49
MINISTRY OF INTERNATIONAL TRADE & INDUSTRY (MITI)Block 10, Government Offices Complex, Jalan Duta 50622 Kuala Lumpur, MalaysiaTel: (603) 6203 3022 Fax: (603) 6203 2337/ 6203 1303 Website: www.miti.gov.my E-mail: [email protected]
MITI OVERSEAS OFFICES
BELGIUMMinister Counsellor (Economy)Mission of Malaysia to the EUEmbassy of Malaysia in BelgiumAvenue de Tervuren 414A1150 BrusselsBelgiumTel: (322) 776 0340/762 5939Fax: (322) 771 2380Email: [email protected]/
CHINA, PEOPLE’S OF REPUBLIC OFMinister Counsellor (Economy)Embassy of Malaysia (Economic Section)No.2 Liang Ma Qiau Bei JieChaoyang District, 100600 BeijingPeople’s Republic of ChinaTel: (8610) 6532 2533/7990Fax: (8610) 6523 3617Email: [email protected]
INDIA, REPUBLIC OFMinister Counsellor (Economy)High Commission of Malaysia in New Delhi50-M, Satya MargChanakyapuriNew Delhi 110021Republic of IndiaTel: (91-11) 2611 1291/1292/
1293/1297Fax: (91-11) 2688 1538Email: [email protected]
INDONESIACounsellor (Economics)Embassy of Malaysia(Commercial Section)Jalan H.R. Rasuna Said, Kav X6No.1-3, KuninganJakarta 12950IndonesiaTel: (6221) 522 4947/522 4962Fax: (6221) 522 4963Email: [email protected]
JAPANMinister Counsellor (Economy)Department of Trade AffairsEmbassy of Malaysia20-16 Nanpeidai-ChoShibuya-ku, Tokyo 150-0036JapanTel: (813) 3476 3844Fax: (813) 3476 4972E-mail: [email protected]
SINGAPORECounsellor (Economics)Malaysian Trade Commission80 Robinson Road #01-02Singapore 068896Tel: (0265) 6222 0126/1356/1357Fax: (0265) 6221 5121Email: [email protected]
SWITZERLANDPermanent Mission of Malaysia to the WTOInternational Centre Cointrin (ICC)3rd Floor, Block C20, Route de Pre-BoisCase Postale 1909CH 1215, Geneva 15SwitzerlandTel: (4122) 799 4040Fax: (4122) 799 4041E-mail: [email protected]
THAILANDCounsellor (Economics)Embassy of Malaysia (Trade Office)35, South Sathorn RoadTungmahamek, SathornBangkok 10120ThailandTel: (662) 679 2190-9
Ext. 2303/ 2304/ 2305Fax: (662) 679 2200E-mail: [email protected]
UNITED STATES OF AMERICAMinister Counsellor (Economy)Embassy of Malaysia3516 International Court NWWashington DC 20008United States of AmericaTel: (1202) 572 9700/10/34Fax: (1202) 572 9782/882E-mail: [email protected]
50 Useful Contacts
MALAYSIA EXTERNAL TRADE DEVELOPMENT CORPORATION (MATRADE)Menara MATRADE, Jalan Khidmat Usaha, Off Jalan Duta, 50480 Kuala Lumpur, MalaysiaTel: (603) 6207 7077 Fax: (603) 6203 7037 Toll Free: 1800-88-7280 Website: www.matrade.gov.my E-mail: [email protected]
EAST - ASIA CHINA, PEOPLE’S REPUBLIC OFBeijingTrade CommissionerEmbassy of Malaysia (Trade Section)Unit E, 11th Floor, Tower BGateway Plaza18, Xiaguangli, North RoadDongsanhuanChaoyang District, Beijing 100027People’s Republic of ChinaTel: (8610) 8451 5109/5110/1113Fax: (8610) 8451 5112E-mail: [email protected]
Chengdu DirectorMalaysia External Trade DevelopmentCorporation (Chengdu Representative Office)Level 14, Unit 1402-1404The Office TowerShangri-La Centre9 Binjiang Road EastChengdu 610021, Sichuan ProvincePeople’s Republic of ChinaTel: (8628) 6687 7517Fax: (8628) 6687 7524E-mail: [email protected]
GuangzhouTrade CommissionerConsulate General of Malaysia (Trade Section)Unit 5305, Citic Plaza Office Tower233, Tianhe Bei RoadGuangzhou, 510610 GuangdongPeople's Republic of China Tel: (8620) 3877 3865/ 3975Fax: (8620) 3877 3985E-mail: [email protected]
Hong KongTrade Commissioner/ConsulConsulate General of Malaysia(Trade Section)19th Floor, Malaysia Building50 Gloucester Road, WanchaiHong Kong Special AdministrativeRegionRegion of the People’s Republic ofChinaTel: (852) 2527 8109Fax: (852) 2804 2866E-mail: [email protected]
ShanghaiTrade Consul Consulate General of Malaysia (TradeSection)Unit 807-809, 8th FloorShanghai Kerry Centre1515, Nanjing Road WestShanghai, 200040 People’s Republic of ChinaTel: (8621) 6289 4420/4467Fax: (8621) 6289 4381E-mail: [email protected]
TAIWANDirectorMalaysian Friendship & Trade Centre(Trade Section)10F-D, Hung Kuo Building167 Dun Hwa North RoadTaipei 105, TaiwanTel: (8862) 2545 2260Fax: (8862) 2718 1877E-mail: [email protected]
MATRADE’S OVERSEAS OFFICES
AUSTRALIATrade CommissionerConsulate of Malaysia (Commercial Section)Level 4, Malaysia Airlines Building 16, Spring Street, SydneyNSW 2000, AustraliaTel: (612) 9252 2270Fax: (612) 9252 2285E-mail: [email protected]
CENTRAL ASIAUZBEKISTANMarketing OfficerTrade Office (MATRADE)Embassy of Malaysia28, Maryam Yakubova Street, Yakkasaray District100 031 Tashkent, Republic of UzbekistanTel: (99871) 256 67 07Fax: (99871) 256 69 09Email: [email protected]
Useful Contacts 51
SOUTH EAST ASIA
CAMBODIAMarketing OfficerMalaysia External Trade DevelopmentCorporation (MATRADE)No. 222, Preah Nurodorn BoulevardSangkat Tonle Bassac KhanChamkarmornPhnom PenhCambodiaTel: (855) 2372 1224Fax: (855) 2372 1225E-mail: [email protected]
INDONESIATrade Commissioner Embassy of Malaysia (Trade Section)12th Floor, Plaza Mutiara Jln. Lingkar Kuningan Kav E.1.2. No1 & 2Kawasan Mega KuninganJakarta 12950Indonesia Tel: (6221) 576 4297/ 4322Fax: (6221) 576 4321E-mail: [email protected]
PHILIPPINESMarketing OfficerEmbassy of Malaysia Trade Office (MATRADE)10/F, The World Trade Centre330 Sen, Gil Puyat AvenueMakati City, PhilippinesTel: (632) 864 0761Fax: (632) 891 1695E-mail: [email protected]
SINGAPOREDirectorMalaysia External Trade DevelopmentCorporation#33-01/03, Shaw Towers 100Beach Road, Singapore 189702Tel: (0265) 6392 2238Fax: (0265) 6392 2239E-mail: [email protected]
THAILANDMarketing OfficerEmbassy of Malaysia (Trade Section)35, South Sathorn RoadTungmahamed, SathornBangkok, 10120, ThailandTel: (662) 679 2190-9 ext 2209
(662) 679 2200/ 2131Fax: (662) 679 2200E-mail: [email protected]
VIETNAMHo Chi Minh CityTrade CommissionerConsulate General of Malaysia (Trade Section)1208, 12th FIoor, Me Linh Point Tower2, Ngo Duc Ke Street, District 1Ho Chi Minh CityVietnamTel: (848) 829 9023/ 8256Fax: (848) 823 1882E-mail: [email protected]
HanoiMarketing OfficerEmbassy of MalaysiaTrade Office (MATRADE)45-46 Dien Bien Phu StreetBa Dinh District, HanoiVietnamTel: (844) 734 7521Fax: (844) 734 7520Email: [email protected]
JAPANTokyoDirectorMalaysia External Trade DevelopmentCorporation6th FIoor, Ginza Showadori Building 8-14-14, Ginza Chuo-kuTokyo 104-0061, JapanTel: (813) 3544 0712/ 0713Fax: (813) 3544 0714Email: [email protected]
OsakaMarketing OfficerMalaysia External Trade DevelopmentCorporation Mainichi Intecio 18F3-4-5, Umeda, Kita-kuOsaka 530-0001 JapanTel : (816) 6451 6520Fax : (816) 6451 6521E-mail: [email protected]
KOREA, REPUBLIC OF Trade CommissionerEmbassy of Malaysia (Trade & Investment Section)17th Floor, SC SC Bank Korea Limited47, Chongro, Chongro ruSeoul 110-702Republic of Korea Tel: (822) 739 6813/ 6814/ 6812Fax: (822) 739 6815E-mail: [email protected]
SOUTH ASIA
INDIAChennaiTrade CommissionerConsulate General of Malaysia (Trade Section)Capitale 2A, 2nd Floor554 & 555, Anna SalaiTeynampet, Chennai-600018IndiaTel: (9144) 2431 3722 / 3723Fax: (9144) 2431 3725E-mail: [email protected]
MumbaiConsulConsulate General of Malaysia Trade Section (MATRADE)Suite 301, 3rd Floor, Noman CentreBlock GBandra Kurla Complex, Bandra (E)Mumbai 400051IndiaTel: (9122) 2659 7272 / 3Fax: (9122)2695 7274E-mail: [email protected]
52 Useful Contacts
EUROPE
FRANCETrade CommissionerService Commercial De MalaisieDe L’ Ambassade De Malaisie90, Avenue Des Champs Elysees75008 Paris, FranceTel: (331) 4076 0000/0034Fax: (331) 4076 0001E-mail: [email protected]
GERMANY Trade Commissioner / ConsulConsulate of Malaysia (Trade Section)MATRADEKastor-Hochhaus (Commerzbank)17th Floor, Platz der Einheit 160327 Frankfurt am MainGermanyTel: (4969) 247 5015-10Fax: (4969) 247 5015-20Email: [email protected]
HUNGARYTrade CommissionerEmbassy of Malaysia (Trade Section)Ground Floor, Museum AtriumDozsa Gyorgy ut 84/b1068 BudapestHungaryTel: (361) 461 0290Fax: (361) 461 0291E-mail: [email protected]
ITALYConsul and Trade CommissionerConsulate of Malaysia (CommercialService)5th FIoor, Via Vittor Pisani 3120124 MilanoItalyTel: (3902) 669 0501Fax: (3902) 670 2872E-mail: [email protected]
THE NETHERLANDSTrade CommissionerEmbassy of Malaysia (CommercialSection)Rustenburgweg 2 2517 KE The HagueThe NetherlandsTel: (31010) 462 7759Fax: (31010) 462 7349E-mail: [email protected]
RUSSIATrade CommissionerEmbassy of Malaysia (Trade Section)Mosfilmovskaya Ulitsa 50Moscow 117192Russian FederationTel: (7495) 147 1514/ 1523Fax: (7495) 143 6043E-mail: [email protected]
UKRAINEMarketing OfficerTrade Office (MATRADE)Embassy of MalaysiaNo. 25 Bulivska StreetPerchersk, Kiev 01014UkraineTel: (38044) 286 7128Fax: (38044) 286 8942Email: [email protected]
UNITED KINGDOMTrade CommissionerMalaysian Trade Commission(Commercial Section)3rd & 4th Floor, 17 Curzon StreetLondon W1J 5HRUnited KingdomTel: (4420) 7499 5255/4644Fax: (4420) 7499 4597E-mail: [email protected]
UZBEKISTANEmbassy of Malaysia28, Maryam Yakubova StreetYakkasaray District100 031 TashkentRepublic of Uzbekistan Tel: (99871) 256 6707Fax: (99871) 256 6909Email: [email protected]
WEST ASIA
SAUDI ARABIATrade CommissionerConsulate General of Malaysia(Commercial Section)14th Floor, Saudi Business CentreMadina RoadP.O.Box 20802Jeddah 21465Saudi ArabiaTel: (9662) 653 2143/ 98Fax: (9662) 653 0274E-mail: [email protected]
UNITED ARAB EMIRATESConsul General / Trade CommissionerConsulate General of MalaysiaMalaysia Trade CentreLot 1-3 Ground Floor & 6-10 Mezzanine FloorsAl-Safeena Building Near Lamcy PlazaZaabeel RoadP.O.Box 4598, DubaiUnited Arab EmiratesTel: (9714) 335 5528/38Fax: (9714) 335 2220E-mail: [email protected]
Useful Contacts 53
NORTH AMERICA
CANADATrade CommissionerConsulate of Malaysia (Trade Office)First Canadian PlaceSuite 3700100 King Street WestToronto, Ontario M5X 1E2CanadaTel: (1416) 504 6111Fax: (1416) 504 8315E-mail: [email protected]
LOS ANGELES, THE USATrade CommissionerConsulate General of Malaysia(Commercial Section)550 South Hope StreetSuite 400, Los Angeles, CA 90071United States of AmericaTel: (1213) 892 9034Fax: (1213) 955 9142E-mail: [email protected]
MIAMI, THE USADirectorMalaysia Trade Centre703 Waterford Way, Suite 150Miami, Florida 33126United States of AmericaE-mail: [email protected]: (1305) 267 8779Fax: (1305) 267 8784E-mail: [email protected]
NEW YORK, THE USATrade CommissionerConsulate General of Malaysia(Commercial Section)3rd Floor, 313 East, 43rd Street New York, NY 10017United States of AmericaTel: (1212) 682 0232Fax: (1212) 983 1987E-mail: [email protected]
SOUTH AMERICA
BRAZILTrade CommissionerEmbassy of Malaysia (CommercialSection)771, Alameda Santos, Suite 727th Floor, 01419-00141, Sao PauloBrazilTel: (5511) 3285 2966Fax: (5511) 3289 1595E-mail: [email protected]
CHILETrade CommissionerOficina Commercial de MalasiaEmbajada De Malasia AvdaTajamar 183Oficina 302, Las CondesSantiagoChileTel: (562) 234 2647Fax: (562) 234 2652E-mail: [email protected]
MEXICOTrade CommissionerEmbassy of Malaysia, Mexico CityPaseo de Las Palmas # 425Torre Optima 3, Office 1101 & 1102Col. Lomas de ChapultepecDel. Miguel Hidalgo, C.P.11000Mexico D.F.Tel: +5255 5201 4540Fax: +5255 5202 7338E-mail: [email protected]
ARGENTINAEmbassy of Malaysia Trade Office(MATRADE)Villanveva 1040C1426B MD Buenos AiresRepublic of ArgentinaTel: (54) 11 4776 0504 / 2553 /
(54) 11 4777 8420Fax: (54) 11 4776 0604E-mail: [email protected]
AFRICA
CAIRO, EGYPTTrade CommissionerEmbassy of Malaysia (Trade Section)17th Floor, North TowerNile City BuildingCornish El-Nil StreetCairoEgyptTel: (202) 461 9063/ 9064Fax: (202) 461 9065E-mail: [email protected]
KENYATrade CommissionerMalaysian Trade CommissionBlock 91/404, Gigiri,Groove, GigiriP.O. Box 4228600200 Nairobi KenyaTel: (25420) 712 0915Fax: (25420) 712 0916E-mail: [email protected]
SOUTH AFRICATrade CommissionerMalaysia Trade CommissionGround Floor, Building 5Commerce Square Office Park39, Rivonia Road, SandhurstSandton, JohannesburgSouth AfricaTel: (2711) 268 2380/ 2381Fax: (2711) 268 2382Email: [email protected]
54 Useful Contacts
JOHORDIRECTORMATRADE Southern Regional OfficeMalaysia External Trade DevelopmentCorporation (MATRADE)Suite 6B, Tingkat 6, Menara Ansar65, Jalan Trus, 80000 Johor Bahru,JohorTel: (607) 222 9400Fax: (607) 222 9500Email: [email protected]
PENANGMalaysia External Trade DevelopmentCorporation (MATRADE)1st Floor, FMM Building 2767, Mukim 1Lebuh Tenggiri 2, Bandar SeberangJaya13700 Seberang Perai Tengah, PulauPinangTel: (604) 398 2020Fax: (604) 298 2288Email: [email protected]
TERENGGANUDIRECTORMATRADE Eastern Regional OfficeMalaysia External Trade DevelopmentCorporation (MATRADE)Tingkat 5, Menara Yayasan IslamTerengganuJalan Sultan Omar, 20300 KualaTerengganu, TerengganuTel: (609) 624 4778Fax: (609) 624 0778Email: [email protected]
SARAWAKMalaysia External Trade DevelopmentCorporation (MATRADE)Tingkat 10, Menara Grand, Lot 42,Section 46Ban Hock Road, 93100 Kuching,SarawakTel: (6082) 246 780 / 248 780Fax: (6082) 256 780Email: [email protected]
SABAHMalaysia External Trade DevelopmentCorporation (MATRADE)Lot C5.2A, Tingkat 5, Block C,Bangunan KWSPJalan Karamunsing, 88100 KotaKinabalu, SabahTel: (6088) 240 881 / 242 881Fax: (6088) 243 881Email: [email protected]
MATRADE STATE OFFICES
Useful Contacts 55
MINISTRIES OF HEALTH MALAYSIABlock E1, E6, E7 & E10, Complex EFederal Government Administrative Centre62590 Putrajaya, MalaysiaTel: (603) 8883 3888 Fax: (603) 2274 7970Website: www.moh.gov.myE-mail: [email protected]
CLINICAL RESEARCH CENTRELevel 3, Dermatology Block,Kuala Lumpur Hospital,Jalan Pahang,50586, Kuala LumpurMalaysiaTel: (603) 26924249/(603) 26911486Fax: (603) 26911682Website:http://www.crc.gov.my
NATIONAL PHARMACEUTICALCONTROL BUREAU (NPCB)Ministry of Health MalaysiaLot 36, Jalan Universiti46200 Petaling JayaSelangorMalaysiaTel: (603) 78835400Fax: (603) 79562924Website:http://www.bpfk.gov.my
PHARMACEUTICAL SERVICESDIVISIONPharmacy Board of MalaysiaMinistry of Health MalaysiaLot 36, Jalan Universiti46350 Petaling JayaSelangorMalaysiaTel: (603) 78413200Fax: (603) 79682222Website: http://www.pharmacy.gov.my
POLICY AND INTERNATIONALRELATIONS DIVISIONMinistry of Health MalaysiaLevel 6, 8 & 11, Complex E, Precinct 1Federal Government AdministrativeCentre, 62590 PutrajayaMalaysiaTel: (603) 8883 2865Fax: (603) 8888 8692Website:http://korporat.moh.gov.my
RELEVANT DIVISIONS/AGENCIES
56 Useful Contacts
BANK NEGARA MALAYSIAJalan Dato’ Onn, P.O. Box 1092250929 Kuala LumpurMalaysiaTel: (603) 2698 8044Fax: (603) 2691 2990Website:www.bnm.gov.myE-mail: [email protected]
COMPANIES COMMISSION OFMALAYSIA (SSM)Menara [email protected], Jalan Stesen Sentral 5Kuala Lumpur Sentral50200 Kuala LumpurMalaysiaTel: (603) 2299 4400Fax: (603) 2299 4411Website:www.ssm.gov.myEmail: [email protected]
DEPARTMENT OFENVIRONMENTMinistry of Natural Resources and EnvironmentLevel 1-4, Podium 2&3, Wisma Sumber Asli, No.25, Persiaran Perdana, Precinct 4Federal Government Administrative Centre62574 PutrajayaMalaysiaTel: (603) 8871 2000/ 8871 2200Fax: (603) 8889 1973/75Website:www.doe.gov.myE-mail: [email protected]
DEPARTMENT OF INDUSTRIALRELATIONSLevel 9, Block D4, Complex DFederal Government Administrative Centre62530 PutrajayaMalaysiaTel: (603) 8871 1205Fax: (603) 8889 2355Website:www.mohr.gov.my/depart/jpp/E-mail: [email protected]
DEPARTMENT OF LABOUR Level 5, Block D3, Complex DFederal Government Administrative Centre62502 PutrajayaMalaysiaTel: (603) 8886 5192Fax: (603) 8889 2368Website:www.jtksm.mohr.gov.myE-mail: [email protected]
DEPARTMENT OFOCCUPATIONAL SAFETY AND HEALTHLevel 2, 3 and 4, Block D3, Complex DFederal Government Administrative Centre62530 PutrajayaMalaysiaTel: (603) 8886 5000Fax: (603) 8889 2443Website:www.dosh.gov.myE-mail: [email protected].
EMPLOYEES PROVIDENT FUNDKWSP BuildingJalan Raja Laut50350 Kuala LumpurMalaysiaTel: (603) 8922 6000Fax: (603) 8922 6222Website:www.kwsp.gov.myE-mail: [email protected]
HALAL INDUSTRYDEVELOPMENT CORPORATION (HDC)5.02, Level 5KPMG Tower, First AvenuePersiaran Bandar Utama 47800 Petaling JayaSelangor Darul Ehsan MalaysiaTel: (603) 7965-5555 Fax: (603) 7965-5500 Hotline: 1800-880-555 Website:www.hdcglobal.comE-mail: [email protected]
IMMIGRATION DEPARTMENTLevel 1 – 7(Podium)No.15, Persiaran Perdana, Precinct 2 Federal Government Administrative Centre62550 PutrajayaMalaysiaTolfree: 1800 22 6969Tel: (603) 8000 8000Fax: (603) 8880 1200Website:www.imi.gov.myE-mail: [email protected]
INLAND REVENUE BOARDMenara Hasil Persiaran Rimba PermaiCyber 8, 63000 CyberjayaSelangorMalaysiaTel: (603) 8313 8888Fax: (603) 8313 7801Website:www.hasil.gov.myEmail: [email protected]
INTELLECTUAL PROPERTY CORPORATION OF MALAYSIAUnit 1-7, Ground FloorMenara UOA BangsarNo.5, Jalan Bangsar Utama 159000 Kuala LumpurMalaysiaTel: (603) 2299 8400Fax: (603) 2299 8989Website:www.myipo.gov.myE-mail: [email protected]
MALAYSIA DEPARTMENT OFISLAMIC DEVELOPMENTLevel 4-9, Block D7, Complex D Federal Government AdministrativeCentre62519 PutrajayaMalaysiaTolfree: 1800 22 224Tel: (603) 8886 4000
(Halal Hub Division)Fax: (603) 8889 2031 Website:www.islam.gov.my
MALAYSIAN BIOTECHNOLOGY CORPORATION SDN BHDLevel 23, Menara Atlan161B Jalan Ampang50450 Kuala LumpurMalaysiaTel: (603) 2116 5588Fax: (603) 2116 5411Website:www.biotechcorp.com.myEmail: shamini.poovendran@
biotechcorp.com.my
MALAYSIAN INDUSTRIALDEVELOPMENT FINANCE BHD (MIDF)21st Floor, Menara MIDF82, Jalan Raja Chulan50200 Kuala LumpurMalaysiaTel: (603) 2173 8888Fax: (603) 2173 8877Website:www.midf.com.myE-mail: inquiry-feedback@
midf.com.my
OTHER RELEVANT ORGANISATIONS
Useful Contacts 57
MALAYSIAN ORGANISATION OFPHARMACEUTICALINDUSTRIES (MOPI)Global Business & Convention CentreMezzanine Floor, Block A No 8, Jalan 19/1, Section 1946300 Petaling Jaya, SelangorMalaysiaTel: (603) 7931 9003 Fax: (603) 7932 2736 Website:www. mopi.org.myE-mail: [email protected]
MALAYSIAN TECHNOLOGYDEVELOPMENT CORPORATION SDN BHD(MTDC)Menara Yayasan Tun RazakLevel 8-9, Jalan Bukit Bintang55100 Kuala LumpurMalaysiaTel: (603) 2172 6000Fax: (603) 2163 7549Website:www.mtdc.com.myE-mail: [email protected]
MALAYSIAN INDUSTRY-GOVERNMENTGROUP FOR HIGHTECHNOLOGY (MIGHT)Block 3517, Jalan Teknokrat 563000 CyberjayaSelangorMalaysiaTel: (603) 8315 7888Fax: (603) 8312 0300Website:www.might.org.myE-mail: [email protected]
ROYAL CUSTOMS MALAYSIALevel 7 North, Ministry of Finance ComplexPrecinct 2No.3 Persiaran PerdanaFederal GovernmentAdministrative Centre62592 PutrajayaMalaysiaTel: (603) 8882 2300/2500/2100Fax: (603) 8889 5901Website:www.customs.gov.myE-mail: [email protected]
SME CORP MALAYSIALevel 6, SME 1, Block BLot E, Jalan Stesen Sentral 2Kuala Lumpur Sentral50470 Kuala LumpurMalaysiaTel: (603) 2775 6000Fax: (603) 2775 6001Infoline: 1-300-88-1801Website:www.smecorp.gov.myE-mail: [email protected]
SME BANKMenara SME BankJalan Sultan Ismail P.O.Box 1235250774 Kuala LumpurMalaysia Tel: (603) 2615 2020/ 2828Fax: (603) 2692 8520/ 2698 1748Website:www.smebank.com.myE-mail: customercare@
smebank.com.my
TELEKOM MALAYSIA BERHADLevel 51, North Wing, Menara TMOff Jalan Pantai Baru50672 Kuala LumpurMalaysiaTel: (603) 2240 1221Fax: (603) 2283 2415Website:www.tm.com.myE-mail: [email protected]
TENAGA NASIONAL BERHAD129, Jalan Bangsar59200 Kuala LumpurMalaysiaTel: (603) 2296 5566Fax: (603) 2283 3686Website:www.tnb.com.myE-mail: [email protected]
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