Scope of the Guidelines
- Applicable to all products classified as FDCs.
- Covers three categories:
- Currently registered products recognized as FDCs by BFAD.
- Currently registered products that may be reclassified as FDCs by BFAD.
- Products pending or for future initial registration as FDCs.
Safety, Efficacy, and Quality Criteria
- FDCs must comply with safety, efficacy, and quality criteria as follows:
- Compliance with A.O. 67 s. 1989 on drug product registration.
- Compliance with A.O. 56 s. 1989 on drug establishment registration.
- Final dosage form must prove:
- Pharmaceutical and pharmacological compatibility of active and inactive ingredients.
- Clinical and therapeutic advantage over separate individual active ingredients, beyond additive effect or improved compliance.
- Absence of ingredients requiring special administration adjustments conflicting with other ingredients.
- Exclusion of active ingredients with abuse potential, narrow safety margins, special precautions, bioequivalence problems, or banned/not registered substances.
- Exemption for FDCs listed in recognized International Compendia and deemed essential by the Department of Health.
Applicability to FDCs Pending or for Future Initial Registration
- New and initial registrations must comply with Section 3 criteria before certificate issuance.
- Registration applications must include:
- Detailed therapeutic/clinical rationale.
- Information on pharmaceutical, pharmacological, and therapeutic properties, including adverse reactions.
- Clinical documentation for efficacy and safety.
- Bioequivalence studies conducted on Filipino patients when applicable.
Applicability to Currently Registered FDCs
- All currently registered FDCs must meet Section 3 criteria.
- BFAD will identify and classify existing FDCs into use groups (Priority I to III) for review.
- Notifications sent to drug establishments about the review.
- Establishments must respond within one week stating intended actions:
- Cease production anticipating registration cancellation.
- Reformulate product to meet requirements.
- Prove compliance with Section 3 criteria.
- Decisions on one product will apply to similar products.
- Maximum 18 months from notice for establishments to:
- Cease production and sell remaining stock; registrations cancelled after 18 months.
- Reformulate product with priority registration processing; old product registration cancelled upon new approval.
- Present evidence of compliance with staged evaluation and decision process over 18 months.
- Only FDCs registered under this Order receive regular registrations; others issued provisional registrations upon current expiration.
Effectivity
- Order effective two weeks after publication in two newspapers of general circulation.
- Supersedes A.O. No. 133 s. 1985 and A.O. No. 7 s. 1986 concerning the same subject.