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Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use

This Administrative Order (AO) is issued to provide the guidelines for the issuance of FDA authorizations and other certifications for pharmaceutical products and active pharmaceutical ingredients including the rules and regulations on registration applications.

This AO shall provide the regulatory guidelines for the following:

  • Identification of registrable pharmaceutical products and active pharmaceutical ingredients;

  • Types of registration applications for pharmaceutical product and active pharmaceutical ingredient authorization;

  • Regulatory review implemented by the FDA on the applications and the applicable evaluation pathways; and

  • Regulatory decisions on the applications.

The AO shall apply to all pharmaceutical products and active pharmaceutical ingredients for human use and for which registration applications are submitted to the FDA for the following authorizations:

  1. Marketing Authorization

  2. DOH-Use-Only Authorization

  3. Foreign Donation Authorization

The applicants must provide comprehensive documentation, including:

Product Information: Detailed description of the pharmaceutical product or API, including its composition, formulation, and intended use.

Quality Data: Evidence of the product’s quality, including manufacturing processes, specifications, and quality control measures.

Safety and Efficacy Data: Clinical and non-clinical data demonstrating the safety and efficacy of the product.

By adhering to these guidelines, pharmaceutical companies can navigate the regulatory process more efficiently, bringing safe and effective products to the market.

For more detailed information, you can read the full draft guidelines here.


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