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

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

National Administrative Register January 13, 2000
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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