Philippines Proposes Administrative Order on GMP and Registration of Health Supplements

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 [email protected] 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)

2. Application Scope & Definition 

The AO covers all health supplements intended for manufacture, use, import, distribution, and sale in the Philippines. It explicitly excludes food/dietary supplements, which are regulated under separate guidelines.

Health supplements: products to supplement diet, enhance health, and improve body function. Contain vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, bioactive substances, or natural/synthetic derivatives. Forms: capsules, tablets, powder, liquids. Exclude sterile preparations like injectables or eye drops.

Food/dietary supplements: processed products to supplement diet with vitamins, minerals, amino acids, herbs, or other dietary substances. Forms include capsules, tablets, liquids, gels, powders, or pills. Not a conventional food, meal replacement, or drug substitute. Complies with Philippine or international nutrient intake standards.

3. GMP for Health Supplements 

The order provides detailed guidelines on GMP for health supplements, covering:

• Quality Management: Ensuring products are fit for intended use and comply with regulatory requirements.

• Personnel: Adequate training and qualifications for all staff.

• Premises and Equipment: Proper design and maintenance to minimize contamination risks.

• Sanitation and Hygiene: High standards to prevent contamination.

• Documentation: Comprehensive records to ensure traceability and quality control.

• Production: Defined procedures to ensure product consistency.

• Quality Control: Independent QC department to oversee product quality.

• Contract Manufacture and Analysis: Clear contracts to ensure quality in outsourced operations.

• Complaints and Product Recalls: Systems for handling complaints and recalling defective products.

• Self-Inspection: Regular inspections to ensure GMP compliance.

For details of GMP for health supplements, please refer to Annex B of this AO.

4. Guidelines for the Registration of Health Supplements 

The registration process shall follow FDA Circular No. 2020-033, with additional requirements covering:

• Prohibited ingredients (Annex D);

• Approved additives and excipients (Annex E);

• Limits on heavy metals and microbial contaminants (Annex F);

• Guidelines for bovine-derived materials (Annex G);

• Stability data and shelf-life requirements (Annex H);

• Additional data to prove the product safety (Annex I);

• Justification for claims (Annex J);

• Labeling requirements (Annex K and AO No. 2014-0030 ).

Once implemented, establishments found violating the order may face application disapproval, suspension, or cancellation of CPR. The order also repeals any inconsistent previous issuances.