Food and Drug Administration (Philippines)


The Food and Drug Administration of the Philippines, formerly the Bureau of Food and Drugs, is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently reorganized by Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”. The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety, efficacy, and quality in the Republic of the Philippines.
The Philippine FDA is led by the Director General appointed by the President of the Philippines and two deputies for Internal Management and Field Regulatory Operations. The Director General reports directly to the Secretary of Health. Rolando Enrique D. Domingo, MD is the incumbent Director General since March 2020.
The FDA has its central office in Alabang, Muntinlupa. The agency has 4 centers located at its central office, and 5 clusters of field regulatory operations and 4 laboratories located throughout the archipelago.

Organizational chart

In the light of the tremendous progress in the food and pharmaceutical industry, the late Department of Health Secretary Francisco Duque Sr. created a subcommittee on Food and Drugs in the year 1961-62 to initiate an administration bill to Congress to enact a law that would ensure the safety, purity and quality of foods, drugs and cosmetics being made available to the public. The Subcommittee on Food and Drug was chaired by the then Undersecretary for Special Health Services, Dr. Rodolfo Caños, with members Dr. Trinidad Pesigan, Director of the Bureau of Research and Laboratories, Mr. Emilio Espinosa of the Bureau of Health Services, Ms. Amor Cita M. Pallera, Pharmacy Adviser, Office of the Secretary of Health, also as Secretary and Liaison to Congress. Thus, on June 22, 1963 Republic Act No. 3720 was passed into law known as the “Food, Drug and Cosmetic Act”.
To carry out the provisions of R.A. 3720, the Food and Drug Administration was created with offices and laboratories constructed in the DOH San Lazaro Compound, Sta. Cruz, Manila at a cost of about Php 2.5M. The Food and Drug Administration became operational with the appointment of its first FDA Administrator, Ms. Luzonica M. Pesigan on May 25, 1966 to Dec. 7, 1977 with Mr. Emilio Espinosa as Deputy Director. By Virtue of R.A. 3720, the powers, functions and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and the Board of Food Inspection, all personnel together with all their equipment, supplies, records, files and balance of appropriations were transferred to the FDA.
After the retirement of the Deputy Administrator, Mr. Emilio Espinosa, Mr. Arsenio M. Regala took over as Deputy Administrator on June 1, 1972.
With the Integrated Reorganization Plan of 1973, the Narcotic Drugs Division, Bureau of Internal Revenue, Department of Finance was Transferred to the Food and Drug Administration headed by Ms. Conception M. Fernandez who retired in 1975 with Ms. Rita V. Caoile as the next chief of the same. Mrs. Catalina C. Sanchez took over as the next chief of the Narcotic Drugs Division in 1976.
Mr. Arsenio M. Regala was appointed FDA Administrator on Dec. 13, 1977 upon the retirement of Ms. Lozonica M. Pesigan on Dec. 7, 1977. Ms. Catalina C. Sanchez was appointed Vice Mr. Arsenio M. Regala as Deputy Administrator on January 13, 1978. On his retirement, Mrs. Catalina C. Sanchez was designated Acting Administrator of FDA on April 5, 1982 to Feb. 19, 1984.
On December 2, 1982, Executive Order No. 851 by Section 4, under the Minister of Health Hon. Jesus M. Azurin, The FDA was abolished and created the Bureau of Food and Drugs. Mrs. Catalina C. Sanchez was appointed the first Director of the BFAD on Feb. 20, 1984 and took her oath on Feb. 28, 1984.
In 1987, the Bureau moved to its new site in Alabang, Muntinlupa City, and acquired new facilities including state-of-the-art analytical instruments and a modern experimental animal laboratory with the $12M grant from the Government of Japan through the Japan International Cooperation Agency. This new BFAD in Alabang became operational on April 30, 1987.
In 1987, R.A. 3720 was amended by Executive Order 175 to the new title “Foods, Drugs, and Devices and Cosmetics Act”.
It was also on the same occasion of the inauguration of this new BFAD facility that Pres. Corazon C. Aquino declared publicly the Philippine National Drug Policy together with its four pillars, i.e., Quality Assurance, Rational Use of Drugs, Self-Reliance, and Tailored Procurement. Based on the issuance of E.O. Nos. 174 and 175 amendments to R.A. 5921 “The Pharmacy Law” and R.A. 3720 “Food, Drug, and Cosmetic Act” respectively, the Philippine National Drug Policy was organized. Executive Order No. 851 was superseded by E.O. No. 119 s. 1987 under Hon. Alfredo R. A. Bengzon, Sec. of Health, that again reorganized the BFAD on the basis of Administrative Order No. 30 s. 1987, Provisions to Implement the Reorganization of the Department of Health.
Executive Order No. 102 dated May 24, 1999 was signed and redirected the functions and operations of the Department of Health, with then Hon. Alberto G. Romualdez, Sec. of Health, wherein BFAD was expanded with an added Division, the Policy, Planning, and Advocacy Division. The joining of the National Drug Policy workforce with that of BFAD in Alabang, further strengthened the Bureau to meet new challenges in serving the interests of the Filipino people consistent with the Philippine National Drug Policy and the National Health Policy.
On the retirement of Mrs. Catalina C. Sanchez on Feb. 1, 1989, Dr. Cecile P. Gonzales took over, followed by Dr. Quintin L. Kintanar ; Dr. William D. Torres, with Deputy Director for Drugs, Dr. Kenneth Hartigan-Go and the lateral transfer of Mrs. Adelisa Ramos, Director III of the DOH Nutrition Service as Deputy Director for Food pursuant to E.O. 102.
On September 1, 2002, Prof. Leticia Barbara B. Gutierrez was appointed new Director of the Bureau.
On April 14, 2009, Ms. Nazarita T. Tacandong, was appointed by the President as an Acting Director of the Bureau.
Republic Act No. 9711, an act strengthening and rationalizing the regulatory capacity of the Bureau of Food and Drugs by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resources complement, giving authority to retain its income, renaming it the Food and Drug Administration, amending certain sections of Republic Act No. 3720, was signed by President on August 18, 2009.
Dr. Suzette H. Lazo, took office as Acting Director in December 2010 with Ms. Nazarita T. Tacandong and Atty. Ronald R. De Veyra as Assistant Directors.
Dr. Kenneth Y. Hartigan-Go was appointed Director IV of the Food and Drug Administration on 23 August 2012 by Benigno Aquino III. Having previously served as Deputy Director at the turn of the millennium, he is familiar with the handicap that the agency deals with, the crucial role it plays in ensuring public health, and its potential for synergistic national growth. Under the flagship of ‘Balancing Innovation and Sound Regulation’, he is prioritizing several key projects that will define the FDA. Most important is the implementation of Republic Act 9711 that reorganizes the agency from divisions based on authorization to product-based centers. The same law puts more teeth into the law enforcement capability of the agency by integrating the regional operations under a single directorate. A law enforcement unit will also be established under every regional office that has functions, powers, and responsibilities similar to the NBI and the PNP. Tying all the projects of together is a spirit of efficiency, transparency and collaboration. He believes in an agency of mature regulators that knows when to deregulate. He considers industry as both an ally and a ward – salient rules and regulations make for easy compliance. At the core of his leadership is a certainty that a strong, effective yet responsive FDA will ensure the health of Filipinos as their vanguard.