REPUBLIC ACT NO. 9711
AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS BFAD BY ESTABLISIHING 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.
Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:
SECTION 1. The Bureau of Food and Drugs (BFAD) is 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 nght to health of the Filipino people; and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower development 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.
SEC. 4.This Act has the following objectives:
(a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction;
(b) To ensure the FDA’s monitoring and regulatory coverage over establishments and products under its jurisdiction; and
(c) To provide coherence in the FDA’s regulatory system for establishments and products under its jurisdiction.
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 shall be under the Office of the Secretary and shall have the following functions, powers and duties:
“(a) 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;
“(c) To analyze and inspect health products in connection with the implementatlOn of this Act;
“(d) 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 regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA;
“x x x
“(h) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality;
“(i) To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non•consumer users of health products 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;
“(j) To issue cease and desist orders motu propio or upon verified complaint for health products, whether or not registered with the FDA: Provided, 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;
“(k) After due process, to order the ban, recall, and/or withdrawal 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;
“(l) 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;
“(n) To conduct, supervise, monitor and audit research studies on health , and safety issues of health products undertaken by ,entities duly approved by the FDA;
“(o) To prescribe standaras, 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 to carry out its duties and responsibilities under this Act.”
SEC. 6. Section 5 of Republic Act No. 3720, as amended, is hereby further amended and new subsections are added to read as follows:
“(a) The Centers shall be established per major product category that is regulated, namely:
“(1) Center for Drug Reguation and Research (to include veterinary medIcllle, vaCCInes and biologicals);
“(2) Center for Food Regulation and Research;
“(3) 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, The Centers shall likewise conduct research on the safety, efficacy, and quality of health products, and to institute standards for the same
“(b) Each Center shall be headed by a director. The Centers shall be so organized, such that each will have, at least, the following divisions:
“(1) Licensing and Registration Division, which shall be responsible for evaluatmg 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
“(3) Laboratory Support Division, which shall be responsible for the conduct of research and appropriate tests and calibration, analyses and trials of products including, but not limited to, assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests as covered by this Act. It shall likewisse provide direct line support to the centers which shall be separate and distinct per major product category that is regulated.
“(c) ‘I’he Administration and Finance Office headed by the deputy director-general for administration and finance shall have at least the following divisions: the Human Resource Development Division; Property and Logistics Management Division; Human Resource Management Division; Assets and Financial Management Division; and the Information and Communication Technology Management Division.
“(d) The Policy and Elanning Office which shall be under the Office of the Director-General shall have, at least a training, advocacy and communications division and shall monitor the performance of the centers for product research and evaluation and standards development.
“(e) The Field Regulatory Operations Office headed by the deputy director-general for field regulatory operations shall include, among others, all the field offices, field or satellite laboratories and the regulatory enforcement units.
“(f) The Legal Services Support Center shall provide legal services to the entire FDA and shall be directly under the Office of the Director General.”
SEC. 7. Section 6 of Republic Act No. 3720, as amended, is hereby further amended, to read as follows:
“(a) The FDA shall be headed by a director general, with the rank of undersecretary, who shall be tasked, among others, to determine the needed personnel and, to appoint personnel, below the assistant director level in coordination with the Secretary of Health.
“(b) The director-general shall be assisted by two (2) deputy directors-general, one for administration and finance and another for field regulatory operations.
“(c) The director-general and deputy directorsgeneral shall be appointed by the President of the Republic of the Philippines.
“(d) The director-general shall, preferably, possess either a university degree in medicine or at least the relevant master’s degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in hislher field of discipline or profession and in any development, manufacturing, regulatory work or quality assurance of products as covered in this Act.
“(e) The Deputy Director-General for Field Regulatory Operations of the FDA shall, preferably, possess the relevant master’s degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in hislher field of discipline or profession and in any development manufacturing, regulatory work or quality assurance of products as covered in this Act.
“(f) The Deputy Director-General for Administration and Finance of the FDA shall be a certified public accountant or shall possess a master’s degree in accqunting, management, economics or any business course, and must have management experience in a position related to his/her field of discipline or profession.
“(g) A person who was previously employed in a regular full-time capacity regardless of its consultative designation at higher management supervisory levels in regulated establishments, including related foundations, shall be disqualified from appointment as director-general and deputy director-general within three (3) years from termination of employment with the said establishment or foundation. All persons who are candidates for appointment as director-general and deputy director-general must disclose all their incomes for the past three (3) years from all establishments regulated by this Act. The directorgeneral and the two (2) deputy directors-general shall, upon assumption into office, declare any conflict of interest with any establishment covered by the FDA, including their foundations.
“(h) Each center and field office shall be headed by a director who shall be assisted by an assistant director. These directors shall be appointed by the Secretary of Health.
“(i) The existing directors of the Bureau of Health Devices and Technology (BHDT) and division chiefs of the BFAD shall be given preference for appointment as directors and assistant directors of their respective centers: Provided, That if the current officers of the BFAD and the BHDT applying for the above positiqus lack the required third level civil, service eligibifity, they will have to comply with the said requirement within three (3) years from their appointment, otherwise their appointment shall be revolfed immediately.”
SEC. 8. Section 7 of Republic Act No. 3720, as amended, is hereby further amended to read as follows:
“The FDA shall review its staffing pattern and position titles subject to the approval of the Secretary of Health.”