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.