S. No, 2645 No, 3293, Republic of the Philippines Congress of the Philippines Aletes Manila Fourteenth Congress Second Regular Session Begun and held in Metro Manila, on Monday, the twenty-eighth day of July, two thousand eight. —s {RerusucAcrNo. 9711] AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND: DRUGS (BFAD) 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 Beit enacted by the Senate and House of Representatives of the Philippines in Congress assembled:SECTION 1. The Bureau of Food and Drugs (BFAD) hereby renamed the Food and Drug Administration (FDA) Sec. 2. This Act shall be known as the “Food and Drug Administration (FDA) Act of 2009". SEC. 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect and promote the right to health of the Filipino people: and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower developiient and research, responsive to the country’s health needs and problems, Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products, SBC. 4. This Act has the folfowing objectives: (a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products uader ita jurisdiction: (b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction; and (©) To provide coherence in the FDA's regulatory system for establishments and products under its juriadiction. SEC. 5. Section 4 of Republic Act No. 3720, as amended, is hereby further amended to read as follows: “SEC. 4, To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration (FDA) in the Department of Health (DOH). Said Administration ghall be under the Office of the Secretary and shall have the following functions, powers and duties: “@)_To administer the effective implementation of this Act and of the rules and regulations issued pursuant to the same; “(b) To assume primary jurisdiction in the collection of samples of health products: “(© To analyze and inspect health products in conection wit ahe implementation of this Act; “(@) To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container; “(e) To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations reg operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA; “xxx "(h) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality; “@ To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health produets to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person; “G) To issue cease and desist orders motu propio or upon verified complaint for health yroducts, whether or not registered with the FDA: rovided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed;“() After due process, to order the ban, recall, gndlor withérawal of any health product found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization; “Q) To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products; “(m) To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products; “() To conduct, éuperviee, monitor and audit research studies ae and safety issues of products undertaken by Pntities duly approved by the FDA; ? in “(o) To prescribe standariis, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act; “(p) To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and “(q) To exercise such other powers and perform such other functions as may be necessary lw carry out its duties and responsibihties under this a SEC, 6. Section 5 of Republic Act No. 3720, as amended, is hereby further amended and new subsections are added to read as follows: “Sec. 5. The FDA shall have the following centers and offices: “(a) The Centers shall be established per major product category that is regulated, namely: “@) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and Biologicals); “(2) Center for Food Regulation and Research; “(@) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and “(4) Center for Device Regulation, Radiation Health, and Research, “These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. ‘he Contero shall likewise conduct research on the safety, efficacy, and quality of health products, and to institute standards for the same. se) Bach, Center shall be headed by a director. The Centers shall be s0 organized such that each will have, at least, the following divisions: “(1) Licensing and Registration Division, which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed; “(2) Product Research and Standards Development Division, which shall be responsible for the conduct of research, development. of standards and regulations, compliance monitoring, and the oversight and audit of related researches that would ensure safety, quality, purity and efficacy of health products, as covered ‘in this Act; and