and drug administration - minda.gov.ph
Post on 15-Jan-2022
0 Views
Preview:
TRANSCRIPT
FOOD AND DRUG ADMINISTRATION
FDA in General
1963RA 3720Creation of FDA
1982EO 851BFAD
2009RA 9711FDA Strengthening
BRIEF HISTORYIV
. BRIEF H
ISTO
RY
MISSIONTo guarantee the safety, quality, purity, efficacy of health products in order to protect and promote the right to health of the general public.
VISIONTo be an internationally recognized center of
excellence in health product regulation by 2026.
In light of the recently concluded FDA Strategic Planning last December 2016, a new Mission-Vision for the FDA was developed.
I. MANDAT
E
PROTECTTHE GENERAL PUBLIC
through the enforcement of its standards
I. MANDAT
E
FDA STANDARDS
SafetyEfficacyQuality Food, drugs, cosmetics, devices, biologicals,
vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances and/or a combination of and/or a derivative thereof
of health products
I. MANDAT
E
FDA Laws, Rules, and Regulations1. R.A. No. 3720 Food, Drugs, Devices and Cosmetics Act2. R.A. No. 9711 The FDA Act of 20093. RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008, 4. RA 6675, or The Generics Act Of 1988, 5. RA 5921, or The Pharmacy Law,6. RA 9211, or The Tobacco Regulation Act of 20037. RA 7394, or The Consumer Act of the Philippines8. RA 7581/10623, or The Price Act9. RA 10611, or The Food Safety Act of 201310. RA 8172, or The ASIN Law,11. RA 8203, or The Special Law on Counterfeit Drug12. RA 8976, or The Food Fortification Law13. RA 9165, or The Comprehensive Dangerous Drugs Act14. RA 9257, or The Expanded Senior Citizens Act of 200315. PD No. 881, or The Household Hazardous Act16. EO No. 51, or The Milk Code of the Philippines17. RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 201218. PD 856, or The Code of Sanitation of the Philippines
Director General
Policy and Planning Service
Legal Services Support Center
Administrative and Finance Service
South Luzon Cluster
North Luzon Cluster
Visayas Cluster
Mindanao East Cluster
Mindanao West Cluster
Center for Device Regulation Radiation Health and Research
Center for Drug Regulation and
Research
Center for Cosmetics Regulation and
Research
CURRENT ORGANOGRAM
Regulatory Enforcement
UnitFood and Drug Action Center
Field Regulatory Operations OfficeInternal Management
Common Services Laboratory
Information and Communication Technology Division
Bids and Awards Committee
FDA QMS Team
Drug GMP Inspectorate
Center for Food Regulation and
Research
HEALTH PRODUCTCENTERS
Center for Cosmetics Regulation and Research
Center for Drug Regulation and Research
Center for Food Regulation and Research
Center for Device Regulation, Radiation Health and Research
Health Product Center Product Jurisdiction
Human Drug
Products
Veterinary Drug
Products
Medical Oxygen
Traditional Medicine
Vaccine and
Biological Products
Cosmetic Products
Household/ Urban
Hazardous Substances
Household Pesticides
Toys and Childcare Articles
Processed Food Products
Raw Materials for Food
Food Supplements
Medical Devices
Radiation-emitting Devices
Health-related Devices
Radiation Facilities
VI. C
ENTE
RS AND
THEIR
MANDAT
ES
Field Regulatory Operations Office
South Luzon Cluster
North Luzon Cluster
Visayas Cluster
Mindanao East Cluster
Mindanao West Cluster
Regional Field Office XRegional Field Office XIRegional Field Office XIII
FDA CORE FUNCTIONS1. Licensing of Establishments
• Manufacturers• Traders• Distributors/Importers/Exporters/Wholesalers• Retailers (Drugstores)
2. Registration of Health Products• Drug• Food and Food Supplements• Medical Devices• Household/Urban Pesticides• Cosmetics (Notification)• Toys and Childcare Articles (Notification)
3. Post-Marketing Surveillance of Regulated Entities
II. CORE FU
NCTIONS
4. Enforcement
FDA CORE FUNCTIONS
• Legal BasisBook II, Article ILicensing of Establishments and Registration of Health Products
The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.
• FDA Marketing Authorizations
1. License To Operate (LTO)
• FDA Marketing Authorizations
1. Certificate of Product Registration
INITIATIVES ON ASF1. Issuance and Posting of FDA Advisories
• FDA Advisory No. 2019-229 dated July 30, 2019• FDA Advisory No. 2019-127 dated May 27, 2019• FDA Advisory No. 2019-023 dated Feb. 15, 2019
Messages
FDA Advisory is issued to the General PublicPublic Warning on the Purchase and Consumption of Processed Pork Meat Products from Identified Countries Affected by African Swine Fever Virus
Messages
Information on the temporary ban on the importation, distribution and sale of ALL processed pork meat products from the countries affected by ASFInformation on ASFListing of countries affected by ASF
1. China 8. Vietnam 15. Moldova 2. Hungary 9. Zambia 16. Belgium3. Latvia 10. South Africa 17. Hongkong4. Poland 11. Czech Republic 18. North Korea5. Romania 12. Bulgaria 19. Laos6. Russia 13. Cambodia 20. Germany7. Ukraine 14. Mongolia
Messages
Public is advised to only consume processed pork meat products which are sourced from countries other than the listed countries affected by the ASF virus
FDA reiterates that it does not allow the registration of processed pork meat products from these ASF virus affected countries
Heightened post-marketing surveillance is being conductedTo hold violators liable under:
R.A. 9711 - FDA Act of 2009 R.A 10611 - Food Safety Act of 2013
FDA Advisories were issued following DA Memorandum Order No. 12, 13, 15, and 18 series of 2019
2. Issuance of FDA Order • FDA Order No. 2019-103 dated July 30, 2019• FDA Order No. 2019-046 dated May 27, 2019• FDA Order No. 2019-045 dated May 27, 2019• FDA Order No. 2018-133 dated Sept. 24, 2018
INITIATIVES ON ASF
Messages
Authorizes the Food-Drug Regulation Officers and REU Officers to conduct Recall and Seizure of Imported Pork Meat Products for Distribution, Offered for Sale, Transfer, and/or for Donation
Messages
Served as warning to importers, distributors, retail outlets, and other dealers of processed pork meat products against the importation, distribution and sale of these banned products
Prosecution pursuant to R.A. 9711, R.A. 10611 and other relevant laws
Assistance of BOC, LGUs and Law Enforcement Agencies to ensure that these products are not brought in, sold or made available in the Philippine market
FDA Orders were issued following the declarations in DA Memorandum Order No. 12, 13, 15, and 18 series of 2019, and DA Order Nos. 18 and 23 series of 2018
STRENGTHENED POST MARKETING SURVEILLANCE
Products monitored: Ma Ling Pork Luncheon Meat Narcissus Chaosansi Gu Long Chaosansi
EXECUTION OF FDA ORDER P822,231 worth
of inventoried, sealed and confiscated processed pork products
Monitoring done in various establishments across Davao Region
Lab Result from BAI: ASF Viral DNA Detected
Product: Sky Dragon Pork Luncheon Meat
Country of Origin: China Based on FDA monitoring,
product is not available in Davao Region
THANK YOU.
top related