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(NAR) VOL. 11 NO.1 / JANUARY – MARCH 2000

[ BFAD BUREAU CIRCULAR NO. 1, S. 2000, January 13, 2000 ]

MORATORIUM ON THE ACCEPTANCE OF APPLICATION OR INITIAL REGISTRATION OF PHARMACEUTICAL PRODUCTS



R.A. 3720, as amended by E.O. No. 175, otherwise known as the Food, Drug and Cosmetic Act, mandated the Bureau of Food and Drugs to adopt measures to ensure the safety, efficacy and quality of drug products being made available to the general public.

For the past years, the number of registered pharmaceutical products and applications for registration remarkably increased. To provide a more efficient service in matters to undertake a review of all pharmaceutical products currently registered. This is to ensure that only those drug products consistently complying with the standards and criteria for registration are made available in the market. Anent to this, a review of all administrative issuances, system and procedures relating to product registration shall likewise be undertaken in view of current developments in pharmaceutical technology.

To facilitate the review process, all concerned personnel of the Product Services Division are enjoined to exert their effort to complete the review process and achieve the objectives.

It is further ordered that the acceptance of applications for initial registration of all pharmaceutical products be temporarily suspended effective immediately until further notice. The suspension shall not apply to the registration of new drugs that are deemed life saving or a major therapeutic importance.

This Order shall take effect immediately.

Adopted: 13 Jan. 2000

(SGD.) WILLIAM D. TORRES, Ph.D.
Director

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