Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 96)
FDCas are pharmaceutical preparations containing two or more pharmacologically-active ingredients in a single formulation or dosage form.
R.A. 3720, also known as the Food, Drugs and Cosmetics Act, as amended by Executive Order 175.
1) Currently registered products identified by BFAD as FDCas; 2) Currently registered products that may later be classified as FDCas by BFAD; 3) Products with pending or future initial registration under the FDCs category.
Safety, efficacy, and quality.
The FDC must show complementary or synergistic pharmacological action or therapeutic effect, or reduction in adverse drug reactions.
No, FDCs must not contain active ingredients with abuse potential (as identified in List A of A.O. 63, s. 1989), those with narrow safety margins, special precautions, bioequivalence problems, or those banned/unregistered in the Philippines.
A detailed therapeutic/clinical rationale, pharmaceutical, pharmacological and therapeutic properties, adverse reactions information, clinical documentation for efficacy and safety, and bioequivalence studies on Filipino patients where applicable.
Eighteen (18) months from the date of BFAD's Notice of Review.
a) Cease production anticipating cancellation; b) Reformulate to meet Section 3 requirements; c) Present evidence to comply with Section 3 requirements.
The current registration shall be cancelled and any remaining products in the market shall be withdrawn.
It took effect two weeks after publication in two newspapers of general circulation from September 19, 1990, and supersedes A.O. No. 133, s. 1985 and A.O. No. 7, s. 1986.
FDCs listed in International Compendia such as the USP, British Pharmacopeia, WHO Compendia, and deemed essential by the Department of Health.