DATCHAYANI.BM.PHARM -I Pharmaceutical

Regulatory Affairs

JSS College Of Pharmacy, Ooty

NAAC ACCREDITEDAICTE APPROVED.

INTRODUCTION HISTORY OF EMA MILESTONES AND ACHEIVEMENTS MISSION OF EMA WHAT THEY REGULATE WHAT THEY DON’T REGULATE HOW THEY WORK ORGANISATION OF EMA EDQM EUDRALEX SCIENTIFIC COMMITTEES OF EMA DRUG APPROVAL PROCEDURES WITH FEES PAYABLE BIOSIMILARS ASMF EU-CTD

CONTENTS

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU).

The Management Board is the European Medicines Agency's integral governance body.

The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.

EMA protects public and animal health in 27 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

EMA serves a market of over 500 million people living in the EU.

INTRODUCTION

HISTORY OF EMA European medical agency was founded in 1995 , has worked

across the European Union (EU) and globally to protect public and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based information on medicines

EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.

 In its first two decades, the Agency recommended the authorisation of a total of 975 human and 188 veterinary medicines.

EMA was set up in 1995 to harmonise the work of existing national medicine regulatory bodies.

20TH ANNIVERSARY OF EMA:- 2015 marked the 20th anniversary of EMA. The Agency produced a

20th anniversary book, which captures the important progress in regulatory science and changes in medicines regulation in the first 20 years,

50 YEARS OF PHARMACEUTICAL LEGISLATION 2015 also marked the 50th anniversary of the introduction of the first EU

legislation on human medicines.

EUROPEAN MEDICAL AGENCY GROWTH CHART

MILESTONES AND ACHEIVEMENTS

MISSION OF EMA:

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

A strapline is incorporated in the EMA logo to represent the three pillars on which all of the EMA's work is based:-

SCIENCE, representing the scientific expertise that guides the EMA in all of its regulatory decision-making.

MEDICINES, representing the EMA's focus on assessing and monitoring medicines to ensure their quality, safety and efficacy.

HEALTH, representing the purpose for which the Agency was created, namely to protect and improve public and animal health.

WHAT DOES THE STRAPLINE IN THE LOGO REPRESENT?

WHAT THEY REGULATE???

• EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients. 

Facilitate development and

access to medicines

• EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.

Monitor the safety of medicines across their

lifecycle

• The Agency publishes clear and impartial information about medicines and their approved uses. This includes public versions of scientific assessment reports and summaries written in lay language.

Provide information to healthcare

professionals and patients

• The vast majority of medicines available in the EU are authorised at national level, either because they were authorised before EMA’s creation or they were not in the scope of the centralised procedure the Agency is responsible for.

Evaluate the initial marketing

authorisation application of all

medicines in the EU.

• The authorisation of clinical trials occurs at Member State level,

Evaluate applications for the

authorisation of clinical trials.

• EMA does not operate laboratories on its premises or elsewhere, and is not involved in conducting clinical trials.

Carry out research or develop medicines.

WHAT THEY DON’T REGULATE ??

• Once a marketing authorisation has been granted, decisions about price and reimbursement take place at the level of each Member State

Take decisions on the price or

availability of medicines.

• National governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare

Develop treatment guidelines

• The legal decision to grant, suspend or revoke a marketing authorisation for any medicine falls under the remit of the European Commission for centrally authorised products, and the national competent authorities of the EU Member States for nationally authorised products.

Issue of marketing authorisations.

The European Medicines Agency

(EMA) works closely with national

competent authorities in a regulatory

network.

The Agency also implements policies and procedures to

ensure it works independently, openly

and transparently.

Upholds the highest standards

in its scientific recommendations

.

HOW THEY WORK??

EMA

ORGANISATION CHART

ADMINISTRATION AND CORPORATE MANAGEMENT AND DIVISIONHUMAN MEDICINES RESEARCH & DEVELOPMENT SUPPORT DIVISIONHUMAN MEDICINES EVALUATION DIVISIONINFORMATION MANAGEMENT DIVISIONSTAKEHOLDERS & COMMUNICATION DIVISIONVETERINARY MEDICINES DIVISION INSPECTIONS, HUMAN MEDICINES PHARMACOVIGILANCE AND COMMITTEES DIVISION

ORGANISATION CHART OF EMA:

The EDQM (EUROPEAN DIRECTORATE FOR QUALITY MEDICINES)is an organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for medicines and their safe use.

The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

MISSION: to contribute to a basic human right; access to good quality medicines and healthcare .

STRUCTURE OF EDQM

EDQM:-

EUDRALEX stands for European Union drug Legislation Medicinal Products for Human Use.

EudraLex is the collection of rules and regulations governing medicinal products in the European Union.

EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: 1. Volume 1 - Pharmaceutical Legislation.

2.Volume 2 - Notice to Applicants.

a. Volume 2A deals with procedures for marketing authorization.

b. Volume 2B deals with the presentation and content of the application dossier.

c. Volume 2C deals with Guidelines.

EUDRALEX

3. Volume 3 - Guidelines. Concerning Medicinal Products for human use in clinical trials

(investigational medicinal products). 4. Volume 4 - Good Manufacturing Practices. 5. Volume 9 - Pharmacovigilance. Concerning Veterinary Medicinal Products: 6. Volume 5 - Pharmaceutical Legislation.

7. Volume 6 - Notice to Applicants.8. Volume 7 - Guidelines.9. Volume 8 - Maximum residue limits. Concerning Medicinal Products for human use in 

clinical trials (investigational medicinal products). 10. volume 10 - Clinical trials.

SCIENTIFIC COMMITTEES OF EMAEMA consist of 7 scientific committees :-

Committee for Medicinal Products for Human Use (CHMP) Pharmacovigilance Risk Assessment Committee (PRAC) Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Committee for Advanced Therapies (CAT) Paediatric Committee (PDCO)

The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use, in accordance with Regulation (EC) No 726/2004.

ROLE OF CHMP:- The CHMP plays a vital role in the marketing procedures for medicines in the European Union :-

centralised procedure:- The CHMP is responsible for:- conducting the initial assessment of medicines for which an EU-wide

marketing authorisation is sought.

post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to an existing marketing authorisation.

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE:-

In case of MUTUAL-RECOGNITION PROCEDURE:- The CHMP arbitrates in cases where there is a disagreement

between Member States concerning the marketing authorisation of a particular medicine .

OTHER IMPORTANT ROLES OF CHMP:- The CHMP publishes a European public assessment report (EPAR)

for every centrally authorised medicine that is granted a marketing authorisation.

It provides provision of assistance to companies researching and developing new medicines;

The preparation of scientific and regulatory guidelines for the pharmaceuticals industry;

Cooperation with international partners on the harmonisation of regulatory requirements for medicines.

The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines. This includes the detection, assessment, minimisation and communication relating to the risk of adverse reactions, while taking the therapeutic effect of the medicine into account.

ROLE OF PRAC:- It has responsibility for the design and evaluation of post-

authorisation safety studies and Pharmacovigilance audit.

The main responsibility of the PRAC is to prepare recommendations on any questions relating to Pharmacovigilance activities related to a medicine for human use.

PHARMACOVIGILENCE RISK ASSESSMENT COMMITTEE

The Committee for Medicinal Products for Veterinary Use

(CVMP) is responsible for preparing opinions on questions concerning medicines for veterinary use.

ROLE OF CVMP:- A core activity of the CVMP is the establishment of MRLs: the

'maximum residue limits' of veterinary medicines permissible in food produced by or from animals for human consumption, including dairy products, meat, honey etc.

THE COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE :-

The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from people or companies seeking 'orphan-medicinal-product designation' for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union.

ROLE OF COMP:- The COMP is responsible for advising the European Commission on

the establishment and development of a policy on orphan medicinal products in the EU,

Assists the Commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products.

COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS

The Committee on Herbal Medicinal Products (HMPC) is the committee at the European Medicines Agency that is responsible for preparing the Agency's opinions on herbal medicines.

The Committee was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States.

ROLE OF HPMC:- The HMPC's activities aim at assisting the harmonisation of

procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework.

COMMITTEE ON HERBAL MEDICINAL PRODUCTS

The Committee for Advanced Therapies (CAT) is responsible for assessing the quality, safety and efficacy of advanced-therapy medicinal products (ATMPs) and following scientific developments in the field.

It was established in accordance with Regulation (EC) No 1394/2007 on ATMPs.

ROLE OF CAT :- The main responsibility of the CAT is to prepare a draft opinion on

each ATMP application submitted to the European Medicines Agency, before the CHMP adopts a final opinion on the granting, variation, suspension or revocation of a marketing authorisation for the medicine concerned.

COMMITTEE FOR ADVANCED THERAPIES

The Paediatric Committee (PDCO) is responsible for assessing the content of paediatric investigation plans and adopting opinions on them. This includes assessing applications for full or partial waivers and assessing applications for deferrals.

The PDCO was established in accordance with the Paediatric Regulation (Regulation (EC) 1901/2006 as amended).

ROLE OF PDCO:- assessing data generated in accordance with agreed PIPs; providing advice on questions on paediatric medicines, at the

request of the Agency's Executive Director or the European Commission;

advising the Agency and the European Commission on the communication of arrangements available for conducting research into paediatric medicines.

PAEDIATRIC COMMITTEE

MEMBERS OF EMA:-

EXECUTIVE DIRECTOR Guido Rasi.

DEPUTY EXECUTIVE DIRECTOR Mr Noël Wathion.

HEAD OF SCIENTIFIC COMMITTEES REGULATORY SCIENCE STRATEGYAnthony Humphreys

MEMBER STATES OF EMA:

EU MEMBER STATES

There are two regulatory steps to go through before a drug is approved to be marketed in the European union.

These two steps are:- Clinical trial application Marketing authorization application.

Clinical trial applications are approved at the Member State level. Marketing authorization applications are approved at both the

Member State or centralized levels.

DRUG APPROVAL PROCESS

CLINICAL TRIAL APPLICATION:-

EU Directive 2001/20/EC (April 2001) sets out the new rules and regulations for the approval and conduct of clinical trials in Europe.

A sponsor submits a clinical trial application to the Competent

Authority in each Member State where the trials are to be conducted.

The Competent Authority has 60 days to review and approve or reject the application.

Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing and quality controls on the drug, and supporting data, such as ,

(a) chemical, pharmaceutical and biological data, (b) non- clinical pharmacological and toxicological data, (c) clinical data and previous human experience.

The supporting data are submitted in the Common Technical Document (CTD) format.

Qualified Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP.

The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance.

CLINICAL TRIAL APPLICATION APPROVAL PROCESS

The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU.

The Clinical Trials Directive (2001/20/EC) came into force in April 2001, harmonizing the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practice (GCP) in the conduct of clinical trials on medicinal products for human use.

The Directive introduced a harmonized procedure for the authorisation to perform a clinical study in any one of the EU Member States.

In addition, it defines the documentation to be submitted to the Ethics Committee as well as the Investigational Medicinal Product Dossier (IMPD) to be submitted to the competent authority for approval.

INVESTIGATIONAL MEDICAL PRODUCT DOSSIER:

MARKETING AUTHORIZATION:-

Following successful clinical trials, the sponsor has to apply for authorization to market the drug in Europe.

Depending on the type of drug product and the intended market, there are. four different types of marketing authorization applications. They are:-

1. Centralised procedure. 2. Mutual recognition procedure. 3. National authorization procedure. 4. Decentralised procedure.

Class Details Legal Type

Full dossier Has to contain the complete data set – CTD Module 1-5 Article 8

Generic Pure generic application Article 10 (1)

Biosimilar Generic Biotech products Article 10 (4)

Bibliographic application, WEU (Well Established Use)

Non-clinical & Clinical Data replaced by – literature - 10 years systematic and documented use of the substance as a medicinal product in the EU

Article 10a

Fixed dose combination applications

pre-clinical data and clinical data for the combination

Article 10b

Informed consent Innovator’s generic product. (Duplicate dossier)

Article 10c

TYPES OF MAA APPLICATIONS:

MARKETING AUTHORIZATION PROCEDURES

LARGE MOLECULE-PROTEIN BASED DRUG

CENTRALIZED PROCEDURE

SMALL MOLECULE SYNTHETIC DRUG

NATIONAL AUTHORIZATION

PROCEDURE

MUTUAL RECOGNITION PROCEDURE

GENERICSABRIDGED NATIONAL

AUTHORISATION PROCEDURE

CENTRALISED PROCEDURE

CENTRALISED PROCEDURE:

PREPARATION OF MARKETING AUTHORIZATION APPLICATION DOSSIER :

The application dossier is divided into four parts: Part I: Summary of the dossier Part II: Chemical/pharmaceutical/biological documentation Part III: Toxico-Pharmaceutical documentation

Part IV: Clinical documentation.

The Mutual Recognition Procedure is stated in Council Directive 93/39/EEC.

In essence, once a drug is approved for marketing authorization by one Member State, it is eligible to apply for marketing authorization in other Member States through the mutual recognition procedure in place since 1998.

Identical applications are submitted to those Member States where marketing authorizations are sought.

The first Member State that reviews the application is called the ’Reference Member State’. It notifies other states, called ‘Concerned Member States’.

MUTUAL RECOGNITION PROCEDURE

Concerned Member States may suspend their own evaluations to await assessment by the Reference Member State.

The decision of the Reference Member State is forwarded to the Concerned Member States.

If the Concerned Member States reject mutual recognition, the matter is referred to the CHMP of the EMA for arbitration.

The EMA forwards its opinion to the European Commission, which makes the final decision. Altogether, the decision process may take up to 300 days if there is no objection, and 600 days when objections are raised.

MUTUAL RECOGNITION PROCESS

This procedure is used whenever a company wants to commercialize a product in only one EU Member State. The National procedure is specific to each country. That is, each

country within the EU has its own procedures for authorizing a marketing application for a new drug.

Sponsors can find information regarding the requirements and procedure of each country on the websites of the regulatory agencies.

To obtain marketing authorization in a country, the application must be submitted to the Competent Authority of that Member State in its own language.

NATIONAL PROCEDURE

The objective of this procedure is to obtain marketing authorizations in several Member States, when no marketing authorization has been granted in the European Community.

The applicant should send an application to the competent authorities of each of the Member States, where there is intent to obtain a marketing authorization.

The applicant may designate a country to act as the Reference Member State (RMS).

The RMS will start the procedure after the application is determined to be complete by both the RMS and all the CMS(s).

The RMS forwards a preliminary Assessment Report on the dossier to the CMS(s) and the applicant within 70 days.

DECENTRALISED PROCEDURE

The CMS(s) is asked to give comments on the proposed national prescription status and to inform the RMS.

On day 105, the RMS will forward all comments to the applicant and stops the clock if necessary, until the applicant prepares a response document.

The RMS prepares a Draft Assessment Report on day 120 and may close the procedure if a consensus has been reached between the CMS(s) and the RMS.

Otherwise, the CMS(s) has 90 more days to approve the Draft Assessment Report, and other documents.

Competent authorities of the RMS and the CMS(s) adopt a decision within 30 days after acknowledgement of their agreement to the Assessment Report and other documents.

At the end of the Decentralized Procedure with a positive agreement, a national marketing authorization will be issued in the RMS and each of the CMS(s).

Fee type Human medicines Veterinary medicines

Marketing-authorisation application (single strength, one pharmaceutical form, one presentation)

From €278,800 From €139,600

Extension of marketing authorisation (level I)

€83,700 €34,900

Type-II variation (major variation)

€83,700 €41,800

Scientific advice From €41,800 to €83,700 From €13,800 to 41,800

Annual fee (level I) €100,000 €33,400

FEES PAYABLE TO EMA:-

Orphan Drug: EU Regulation on orphan medicinal products EC 141/2000 and EC 847/2000 apply for products intended for treatment of rare diseases.

If a medical condition does not affect more than 5 in 10,000 persons in the Community an orphan designation may be applied for.

Prove of the prevalence of a rare condition should follow COMP/436/01.

The designation procedure with the COMP takes 90 days plus 30 days for Commission approval.

Additionally, the sponsor has to file an application for a marketing authorisation through the centralised procedure and only after approval may bring the orphan drug product on the EU market.

The approval includes a 10 years exclusive marketing right.

ORPHAN DRUG PROCEDURE

EVALUATION OF ORPHAN DRUGS:-

The Herbal Directive (Directive 2004/24/EC) was adopted to facilitate the placing on the EU market of traditional herbal medicinal products.

In particular, herbal products marketed in the form of food supplements should comply with Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.

SIMPLIFIED PROCEDURE:- The simplified procedure allows the registration of traditional herbal

medicinal products, including Chinese or Ayurvedic herbal medicinal products or herbal medicinal products from any other tradition, without requiring tests and trials on safety and efficacy, which the applicant is normally obliged to provide.

Instead for registration of traditional herbal medicinal products, the applicant has to only provide sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the European Union.

HERBAL DRUG MAA PROCEDURE:-

A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine),

EVALUATION OF BIOSIMILARS IN EU:- The main part of the evaluation is a comparison of the biosimilar

with its reference medicine to show that there are no significant differences between them.

WHAT THEY WILL COMPARE???? The relevant regulatory authority applies stringent criteria in their

evaluation of the studies comparing the quality, safety and effectiveness of the two medicines.

BIOSIMILARS:-

comprehensive comparisons of the structure and biological activity of their

active substances

will check for any significant differences in their

benefits and risks, including the risk of immune reactions.

Effectiveness of the drug

COMPARISON STUDIES:-

Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) are granted by the Certification Secretariat of the European Directorate for the Quality of Medicine.

CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorization to demonstrate the compliance of the substance with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.

By means of a CEP, an API manufacturer will be able to provide proof that the quality of a substance is suitably controlled by the relevant monographs of the European Pharmacopoeia, and whether it can be used in medicinal products.

CERTIFICATE OF SUITABILITY TO THE MONOGRAPH OF EUROPEAN PHARMACOPOEIA (CEP)

Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Economic Area must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC.

This means that: 1. clinical trials conducted in the EEA have to comply with European Union (EU) clinical-trial legislation (Directive 2001/20/EC);

2. clinical trials conducted outside the EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to international good clinical practice and the Declaration of Helsinki.

CLINICAL TRIALS IN EU:

The European Medicines Agency is responsible for coordinating inspections to verify compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) and good pharmacovigilance practice (GVP).

Inspections also verify compliance with other aspects of the supervision of authorised medicinal products in use in the European Union.

These are described in Regulation (EC) 726/2004, in Directive 2001/83/EC and in Directive 2001/82/EC.

Sampling and testing:-

The Agency also implements a sampling and testing programme aimed at supervising the quality of centrally authorised medicines available on the European market.

INSPECTIONS:-

Active Substance Master File (ASMF) is otherwise known as European drug master file(EDMF).

OBJECTIVE:- The main objective of the Active Substance Master File (ASMF) procedure, is to allow valuable confidential intellectual

property or 'know-how' of the manufacturer of the active substance (ASM) to be protected.

while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.

ASMFs linked to human and veterinary medicinal products should be presented in the format of the Common Technical Document (CTD).

ACTIVE SUBSTANCE MASTER FILE:

SCIENTIFIC INFORMATION IN THE ASMF: The scientific information in the ASMF should be physically divided

into two separate parts, namely:- 1. APPLICANT’S PART (AP): The AP contains the information that the ASMF holder regards as

non-confidential to the Applicant/MA holder. 2. RESTRICTED PART (RP): RP contains the information that the ASMF holder regards as confidential. ASMF can only be submitted in support of an MAA or MAV

The ASMF holder should submit the ASMF to the National Competent Authority/EMA either for each MAA and each MAV or only once according to national requirements.

The European union Common Technical Document (EU-CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use in the European Union,

European adopted CTD submission since 2003.

eCTD IN THE CENTRALISED PROCEDURE: In centralised procedure the EMA now only accepts submissions

received in eCTD format. Since January 2013 and "Mandatory from March 2014" all eCTD

submissions must be sent using the dedicated submission channels: eSubmission Gateway or the related eSubmission Web Client

EU-CTD

eCTD IN THE MUTUAL RECOGNITION /DECENTRALISED PROCEDURE:-

To facilitate the use of eCTD as the highly recommended submission format in the MRP and DCP, a Best Practice Guide is published by the CMDh

Intas Biopharmaceuticals Limited a mid-sized generic formulation manufacturer located in Ahmedabad, India.

The company faced EU-GMP (Good Manufacturing Practice) audit in December 2006, to seek approval of clinical trial of its biosimilar Filgrastim in Europe and was certified as EU-GMP compliant in April 2007, becoming the first company in India to receive such certification for biologics facility.

Accofil also received marketing authorisation in the European union.

EU-GMP CERTIFIED COMPANIES IN INDIA:

DRUG NAME ACTIVE INGREDIENT

THERAPEUTIC AREA

DATE OF AUTHORISATION

MARKETING AUTHORISATION HOLDER

Truberzi Eluxadoline Irritable Bowel Syndrome,Diarrhoea

19/09/2016 Aptalis Pharma SAS

Cabometyx cabozantinib s-malate

Carcinoma, Renal Cell

09/9/2016 Ipsen Pharma

Nordimet Methotrexate Rheumatoid Arthritis, juvenile Arthritis

18/08/2016 Nordic Group B.V.

Airexar Spiromax

salmeterol / fluticasone propionate

Asthma,COPD

18/08/2016 Teva B.V

DRUG UPDATES:NEWLY AUTHORISED DRUGS:

DRUG NAME ACTIVE INGREDIENT

THERAPEUTIC AREA

DATE OF ADOPTING POSITIVE OPINION

APPLICANT

Ocaliva obeticholic acid

Liver Cirrhosis 13/10/2016 Intercept pharma ,ltd

Rekovelle follitropin delta

intended for controlled ovarian stimulation in women undergoing assisted reproductive technologies (ART).

13/10/2016 . Ferring Pharmaceuticals A/S

HUMAN DRUGS WHICH RECEIVED POSITIVE OPINION FROM CHMP:-

DRUG NAME ACTIVE INGREDIENT

THERAPEUTIC AREA

DATE OF ADOPTING POSITIVE OPINION

APPLICANT

Halagon halofuginone It is used to prevent diarrhoea in new born calve

06/10/2016 Emdoka BVBA

Cepedex dexmedetomidine hydrochloride

Intended for sedation and analgesia in dogs.

06/10/2016 CP-Pharma Handelsgesellschaft mbH

VarroMed oxalic acid dihydrate / formic acid

treatment of Varroa-mite infestation

06/10/2016 BeeVital GmbH

VETERINARY DRUGS WHICH RECEIVED POSITIVE OPINION FROM CHMP:-

GUIDELINES THAT ARE RECENTLY UPDATED:

DATE OF RELEASE OR ADDITION

GUIDELINES

15/08/2016 Better monitoring of biological medicinesNew chapter in guidelines on good pharmacovigilance practices

11/08/2016 Data integrity: key to public health protectionNew guidance now available on EMA’s website

Office address European Medicines Agency

30 Churchill PlaceCanary Wharf

London E14 5EUUnited Kingdom

Tel. +44 (0)20 3660 6000Fax: +44 (0)20 3660 5555

CONTACT DETAILS:-

www.ema.europa.eu/

Review article by Santosh Kumar Narla “MARKETING AUTHORIZATION OF HUMAN MEDICINAL PRODUCTS TO EUROPEAN UNION/EUROPEAN ECONOMIC AREA “. Volume 10, Issue 1, September – October 2011; Article-001.

Review article by K. P. R. Chowdary*, K. Ravi Shankar and G. Saranya “A COMPARATIVE STUDY OF DRUG APPROVAL PROCESS IN UNITED STATES, EUROPE AND INDIA “. Volume 4, Issue 7, 419-427.

Life science Technical bulletin by arash ghaLamkarPour “MARKETING AUTHORIZATION PROCEDURES IN THE EUROPEAN UNION – MAKING THE RIGHT CHOICE”. issue n°33 /december 2009.

REFERENCES:-

THANKS FOR

LISTENING.