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Philippines Proposes Administrative Order on GMP and Registration of Health Supplements

The draft provides guidelines on GMP for health supplements, covering quality management, personnel, premises and equipment, sanitation and hygiene, documentation, production, quality control, contract manufacture and analysis, etc. It outlines the requirements for registration process, ingredients, heavy metals and contaminants, stability test, labeling and claims.

On January 9, 2025, the Philippines FDA issued a draft administrative order (AO) titled "Rules and Regulations Covering the Good Manufacturing Practices (GMP) and Registration of Health Supplements Product under the Center for Food Regulation and Research (CFRR)", which seeks to ensure the safety, quality, and efficacy of health supplements available in the market. Any comments can be sent to gapascual@fda.gov.ph by January 31.

1. Objective 

The primary objectives of the AO are to:

  • Provide GMP requirements for the licensing of health supplement manufacturers.

  • Outline the registration process and requirements for health supplements.

  • Reference international standards for the regulation and registration of health supplements. (Refer to Annex A and C of this AO)

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