Section 20August 18, 2009, Sec./Art. 20

A new chapter XIV and three new sections, Sections 35, 36, and 37 shall be introduced, which shall read as follows:

"CHAPTER XIV

"TESTING LABORATORIES AND FIELD OFFICES

"SEC. 35. The FDA is hereby mandated to improve, upgrade and increase the capability of the agency, to test, calibrate, assay and examine samples of health products. For the purpose of achieving the above mandate, there shall be established at least one (1) testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and appropriate state-of-the-art laboratory equipment and personnel complement.

The main testing laboratories at the central office shall be maintained and shall serve as a support unit to the centers for product research and evaluation and standards development and shall serve as testing centers that would include assay and the conduct, supervision, oversight and/or audit of bioequivalence and bioavailability test/researches, among others. The existing laboratories in Cebu and Davao will be upgraded and transformed as quality assurance laboratories, while another one will be established in Subic, Zambales.

"The testing laboratories may be increased by the director-general, upon approval of the Secretary. Moreover, the director-general, upon approval of the Secretary, may call upon other government and private testing laboratories to conduct testing, calibration, assay and examination of samples of health products: Provided, That the private testing laboratories are accredited by the Philippine Accreditation Office (PAO) of the Department of Trade and industry (DTI) and the DOH."

"SEC. 36. The FDA shall establish field offices in all regions of the country to effectively implement its regulatory functions. The current regional food and drug regulatory officers and regional health physicists in every regional office of the DOH shall now be put under the FDA's sole control and supervision.

The regional field office shall also assume primary jurisdiction in the collection of samples of food, drugs, devices and cosmetics being imported or offered for import at a port of entry other than Manila in his/her assigned region and where it appears that said items or products satisfy any of the conditions as provided for in Section 33(a) of Republic Act No. 3720, as amended, without prejudice to the exercise of the powers of the director-general provided under Sections 13 and 14 of this Act in the exercise of the agency's regulatory functions.

The field offices shall be comprised of the following: (a) licensing, inspection and compliance division, which shall have charge of the inspection of food, drugs and cosmetic establishments engaged in their manufacture, importation, distribution, and sale; (b) satellite laboratory division; and (c) administrative division."

"SEC. 37. The FDA, with the approval of the Secretary, shall create organizational units which are deemed necessary to address emerging concerns and to be abreast with internationally acceptable standards. There shall be created additional plantilla positions to augment the human resource complement of the FDA, subject to existing rules and regulations."