On June 22,1963, under Republic Act No. 3720, the Food and Drug Administration (FDA) was created in the DOH San Lazaro Compound, Sta. Cruz, Manila.
On December 2, 1982 thru Executive Order no. 851 Section 4, FDA was abolished and Bureau of Food and Drugs (BFAD) has been created.
In 1987, the bureau moved to it s new location in Alabang, Muntinlupa City and obtained new services such as state-of-the-art analytical apparatus and animal laboratory with the cooperation of Japan International Cooperation Agency (JICA) which donated $12M.
And on August 18, 2009, the president signed Republic Act No. 9711, an act of 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 resource complement, giving authority to retain its income, renaming it the Food and Drug Administration (FDA), amending certain sections of Republic Act No. 3720, as amended, and appropriating funds thereof.
(FDA) Food and Drug Administration’s 50 years (1963- 2013) have been marked by significant milestones and achievements not only to the institution but to the industry as well.
Advancement on the existing FDA’s regulatory programs to generate new equipments, principles, and harmonized assessment directed to its main goal which is to ensure the safety, efficacy, purity, and quality of products they regulate through effective implementation of the national regulatory framework consistent with international best practices.
The administration is already embracing innovations by changing its documentation system from manual processing to a computerized submission or the e-submission.
FDA moves forward to more transparent regulatory administration via sharing information to public that is easily reached to promote a healthier insight of the administration’s functions and campaigns.
The FDA made it more efficient regulatory administration through public information and opinion exchange accessible at the FDA forum website.
The FDA performs a ground-breaking effort to transform from a major locally-focused agency operating in an interdependent economy to a modern regulatory government body fully equipped for a multifarious globalized regulatory situation.
FDA enters mutual agreement of regulatory requirements for pharmaceutical products with the ASEAN Member States through adaptation of ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR) to decrease technical barriers among the states and to build a strong partnership with the regulatory authorities and the pharmaceutical industry.
The FDA was able to achieve notable accomplishments such as ISO Certification 17025 2005, established partnership with the European Commission to support various FDA projects among others.
The FDA is in a continuous process of developing new strategic plans to face a more complex regulatory environment without compromising the public health and awareness.
Benelyn Nietes RPh
Regulatory Affairs Specialist