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Medicinal Products Regulatory Support in Philippines – Overview

The Philippines pharmaceutical market is expanding, supported by a strong public healthcare system and evolving FDA Regulatory processes. All medicinal products — including prescription, OTC, and biologicals — must be registered with the Center for Drug Regulation and Research (CDRR) under FDA Philippines before being marketed or imported.

To obtain registration, companies must prepare dossiers in ASEAN Common Technical Document (ACTD) format, provide GMP evidence, and comply with local labeling and shelf-life requirements.

Freyr assists pharmaceutical companies through every step — from classification and dossier strategy to submission, evaluation support, and approval ensuring seamless compliance with FDA Philippines.

Medicinal Product Classification in the Philippines

Medicinal products are regulated under RA 3720 and RA 9711 and categorized as follows:

• Prescription Drugs (Rx): Require a physician’s prescription.
• Over the Counter (OTC) Medicines: Safe for self-administration with proven efficacy.
• Biological Products: Include vaccines, blood products, and biosimilars; require additional quality and comparability data.
• Herbal and Traditional Medicines: Must comply with FDA’s specific labeling and safety standards.

All categories must secure a Certificate of Product Registration (CPR) before being marketed in the Philippines.

Medicinal Product Registration & Approval Process in the Philippines

Regulatory Authority: Food and Drug Administration (FDA Philippines)
Legislation: Republic Act No. 3720; RA 9711; related Administrative Orders

Key Steps:

• Pre-Submission Preparation
   Classify the product (Rx, OTC, biologic, vaccine, etc.) and ensure the Marketing Authorization Holder (MAH) is a Philippine-registered entity.
• Application via eServices Portal
   Submit the application online through the FDA eServices Portal in ACTD/ACTR format with GMP, CPP, formulation, and labeling documents.
• Screening
   FDA checks dossier completeness and formatting; incomplete submissions are returned for correction.
• Technical Evaluation
   FDA reviews quality, safety, and efficacy data. New drugs may require clinical evidence; generics need bioequivalence data.
• Registration Approval & CPR Issuance
   Upon approval, FDA issues a Certificate of Product Registration (CPR) authorizing import, distribution, and marketing.
• Import License
   Locally authorized companies must secure an FDA Import Permit for all overseas-manufactured products.
• Pharmacovigilance System
   Establish a PV system and report all serious adverse reactions to FDA’s Pharmacovigilance unit.
• Labeling Compliance
   Labels must follow FDA standards — in English/Filipino, with dosage, usage, and approved claims only.
• Post-Approval Variations
   Changes to formulation, packaging, or site require prior FDA approval through a variation application.
• Renewal & Post-Market Surveillance
   CPRs are valid for 5 years; renew 90 days before expiry. Maintain ongoing surveillance, ADR reporting, and GMP compliance.

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Specific Requirements by Product Type

• Generics: Require bioequivalence data.
• Biologics/Biosimilars: Must meet WHO and FDA comparability standards.
• OTC Products: Simplified registration pathway but mandatory labeling compliance.

Post-Approval & Pharmacovigilance

Registered products are subject to post-market surveillance by FDA Philippines:

• Renewal: Every 5 years with updated product and GMP data.
• Variations: All changes to formulation, labeling, or manufacturing site require FDA approval.
• Pharmacovigilance: Marketing Authorization Holders must report Adverse Drug Reactions (ADRs) in line with FDA Circulars.
• Quality Monitoring: Routine sampling and inspection by FDA’s Center for Drug Regulation and Research (CDRR).

Freyr ensures comprehensive post-approval lifecycle management to maintain ongoing compliance.