3. Ingredient Requirements

Ingredients Regulation Overview for Ingredient Manufacturers
Philippines

This section provides the ingredient requirements for the product categories in scope.

3.1 Ingredients for Drug Products

3.1.1 Drug APIs

The Philippines FDA has adopted the PIC/S Guideline PE 009-14 (Part II) to provide guidance regarding good manufacturing practice requirements for the manufacture of APIs.

3.1.2 Drug Excipients

In accordance with the PIC/S Guideline PE 009-14 (Part I), excipients and excipient suppliers should be controlled appropriately based on the results of a formalized quality risk assessment in accordance with the PIC/S Guideline PI 045-1 ‘Guidelines on the formalized risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use’.

3.1.3 Premixes

The PIC/S Guideline PE 009-13 adopts ICH Q7A, therefore the API manufacturer should designate and document the rationale for the point at which production of the API begins, and from this point on, appropriate GMP should be applied.

3.2 Ingredients for Health Supplements

Ingredients must be manufactured in line with appropriate standards of quality and safety. Acceptable certifications to demonstrate compliance are:

1. Valid manufacturer’s certificate of registration with GMP compliance
2. Phytosanitary Certificate/Health Certificate
3. ISO 22000 Certification
4. HACCP Certificate issued in the country of origin
5. Certificate of Free Sale

3.2.1 Health Supplement Active Substances

Health supplements containing vitamins and minerals are classified as medium-risk products in the Philippines. Where a standard of identity has been established, the manufacturer must be able to demonstrate compliance with that standard through the provision of Certificates of Analysis.

3.2.2 Health Supplement Excipients

Excipients for food supplements in pharmaceutical dosage forms such as tablets, soft gel capsules, and capsules must be listed in the latest Codex General Standards for Food Additives (GSFA) and/or the latest FDA Listing of Food Additives and/or approved pharmaceutical excipients list to be eligible for a Certificate of Product Registration.

3.2.3 Health Supplement Premixes

According to AO No. 2014-0029, “raw materials or ingredients would have product specifications that comply with the client requirements and not necessarily a single component”. Therefore, premixes must be controlled through appropriate specifications. If premixed ingredients are used in health supplements, the specific components must be listed.

3.3 Ingredients for Veterinary Products

Since September 2022, veterinary drugs have been regulated by the Center for Drug Regulation and Research, with the Food and Drug Administration Act of 2009 applying to their manufacture. Therefore, the quality and safety requirements of ingredients are the same as for human drugs.

3.4 References

1. Food and Drug Administration Act of 2009

https://www.fda.gov.ph/wp-content/uploads/2021/04/Republic-Act-No.-9711.pdf

2. PIC/S PE 009-14 Guide to Good Manufacturing Practice for Medicinal Products Part I

https://www.fda.gov.ph/wp-content/uploads/2022/12/PE-009-14-GMP-Guide-Part-I.pdf

3. PIC/S PE 009-14 Guide to Good Manufacturing Practice for Medicinal Products Part II

https://www.fda.gov.ph/wp-content/uploads/2022/12/PE-009-14-GMP-Guide-Part-II.pdf

4. Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf

5. FDA Advisory No. 2022-0591 Marketing Authorization of Veterinary Drugs, Products, Vaccines, Biologicals and Medical Devices

https://www.fda.gov.ph/fda-advisory-no-2022-0591-marketing-authorization-of-veterinary-drugs-products-vaccines-biologicals-and-medical-devices/