RA 9711

• The Bureau of Food and Drugs (BFAD) is hereby renamed the Food and Drug Administration (FDA)
• 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 (c) To provide coherence in the FDA's regulatory system for establishments and promote products under its jurisdiction; and under its jurisdiction
• This Act shall be known as the "Food and Drug Administration (FDA) Act of 2009
• REPUBLIC ACT No. 9711
• Section 4 of Republic Act No. 3720, as amended, is hereby further amended to read as follows
• AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO TESTING LABORATORIES AND FIELD OFFICES. UPGRADING ITS EQUIPMENT 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
• 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 development and research responsive to the country's health needs and problems. Pursuant to this policy, the State mush 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
• 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 c issued pursuant to the same; (b) To assume primary jurisdiction in the collection of samples of health products, "(e) To analyze and inspect health products in connection with the implementation 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; 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; "(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 complaints 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 days (30) 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 concemed to implement the risk management plan which is a requirement for the issuance of the appropriate authorization. ") 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 a
• The FDA is headed by a director-general


  With the rank of undersecretary
• Regulating the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship, use, and testing of health products

  Instituting standards for the same
• Developing and issuing standards and appropriate authorizations


  Covering establishments, facilities, and health products
• Policy and Planning Office responsibilities

  Training, advocacy, communications division, monitoring the performance of the centers for product research and evaluation, and standards development
• Maintaining bonded warehouses and/or establishing the same


  When necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry
• Organizing Centers with divisions

  Licensing and Registration Division, Product Research and Standards Development Division, Laboratory Support Division
• Exercising other powers and performing other functions


  Necessary to carry out duties and responsibilities under this Act
• Conducting, supervising, monitoring, and auditing research studies on health and safety issues of health products

  Undertaken by entities duly approved by the FDA
• Field Regulatory Operations Office responsibilities

  All field offices, field or satellite laboratories, regulatory enforcement units
• Risk management plan implementation

  Requirement for the issuance of the appropriate authorization
• The director-general is tasked to determine the needed personnel and to appoint personnel below the assistant director level


  In coordination with the Secretary of Health
• Establishing centers and offices


  Center for Drug Regulation and Research, Center for Food Regulation and Research, Center for Cosmetics Regulation and Research, Center for Device Regulation, Radiation Health, and Research
• Strengthening the post market surveillance system

  Monitoring health products and incidents of adverse events involving such products
• Prescribing standards, guidelines, and regulations with respect to information, marketing activities about health products


  Covered in this Act, advertisements, marketing instruments, promotion, sponsorship, and other marketing activities
• Legal Services Support Center responsibilities


  Providing legal services to the entire FDA
• Administration and Finance Office responsibilities

  Human Resource Development Division, Property and Logistics Management Division, Human Resource Management Division, Assets and Financial Management Division, Information and Communication Technology Management Division
• Definition of 'FDA'
• Disqualification criteria for appointment as director-general

  A person previously employed in a regular full-time capacity at higher management supervisory levels in regulated establishments, including foundations, shall be disqualified from appointment as director-general within three years from termination of employment. Candidates for appointment as director-general must disclose all their incomes for the past three years. The director-general and deputy directors-general must declare any conflict of interest with establishments covered by the FDA upon assumption into office
• Appointment process for Center and field office directors and assistant directors

  The Secretary of Health appoints the directors and assistant directors of each Center and field office. Existing directors of the Bureau of Health Devices and Technology (BHDT) and division chiefs of the BFAD are given preference for appointment as directors and assistant directors of their respective centers. If the current officers applying for these positions lack the required third level civil service eligibility, they must comply with the requirement within three years from their appointment
• Definition of 'Food'
• Revision of staffing pattern and position titles by the FDA
• Appointment process for the FDA director-general and deputy directors-general

  The President of the Republic of the Philippines appoints the director-general and deputy directors-general. The director-general should preferably possess a university degree in medicine, a relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in regulatory management. Additionally, they should have management experience in their field of discipline or profession and in development, manufacturing, regulatory work, or quality assurance of products as covered in the Act. The Deputy Director-General for Field Regulatory Operations should preferably possess a relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in regulatory management, and have management experience in their field of discipline or profession. The Deputy Director-General for Administration and Finance should be a certified public accountant or possess a master's degree in accounting, management, economics, or any business course, and must have management experience in a position related to their field of discipline or profession
• Definition of 'Drug'
• Medical device


  Any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended for specific purposes related to human beings
• Authorization

  Permission granted by the FDA to a natural or judicial person for various activities related to health products
• Cosmetics


  Substances or preparations intended for external parts of the human body or oral cavity for cleaning, perfuming, changing appearance, correcting body odor, protecting the body, or keeping them in good condition
• Manufacturer


  Establishment engaged in all operations involved in the production of health products
• Articles intended to affect the structure or function of the body of humans or animals are included
• Supplements recognized and adopted by the FDA include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals
• Device

  Medical devices, radiation devices, and health-related devices
• Bioequivalence


  Rate and extent of absorption of a drug
• Distribute means the delivery or sale of any health product for the purpose of distribution in commerce, excluding manufacture or retail