Section 6August 18, 2009, Sec./Art. 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:

"(1) Center for Drug Regulation and Research (to include veterinary medicine, 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 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

"(3) Laboratory Support Division, which shall be responsible for the conduct of research and appropriate testa 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 likewise provide direct line support to the centers which shall be separate and distinct per major product category that is regulated.

"(c) The 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 Planning 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."