3. Ingredient Requirements

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Ingredients Regulation Overview for Ingredient Manufacturers
Vietnam

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

3.1 Ingredients for Drug Products

3.1.1 Drug APIs

Drug APIs must be manufactured at a facility with a production license or certificate of eligibility for pharmaceutical business with the scope of manufacturing drugs and medicinal ingredients issued by a competent authority.

Circular 35/2018/TT-BYT- “Good manufacturing practices for pharmaceutical products and pharmaceutical starting materials” adopts the WHO, PIC/S, and EU-GMP Principles, therefore the GMP requirements for the manufacture of drug APIs are in line with these international regulations.

According to the Law on Pharmacy 2016, medicinal materials must satisfy quality standards and be of clear origin. Circular 11/2018/TT-BYT on Drug/Drug Ingredient Quality provides for the application of quality standards. Where a monograph exists, ingredients must comply with the standards of the Vietnamese Pharmacopeia or other reference pharmacopeia:

European Pharmacopeia
British Pharmacopeia
USP-NF
International Pharmacopeia (WHO)
Japanese Pharmacopeia

3.1.2 Drug Excipients

In accordance with Circular 08/2022/TT-BYT “Regulations on Registration of Circulation of Drugs and Medicinal Ingredients”, if excipients are not manufactured in accordance with the GMP for medicinal materials, the drug manufacturer should conduct a self-assessment of the facility’s compliance with good manufacturing practices. It should be stated in the drug registration dossier the principles and practical standards of good production practice that the excipient manufacturer meets. This regulation is in line 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

Since Circular 35/2018/TT-BYT adopts the WHO, PIC/S, and EU-GMP Principles, 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

3.2.1 Health Supplement Active Substances

It is the responsibility of health supplement manufacturers to control the quality of their products in accordance with Circular No. 13/VBHN-BYT of the Minister of Health “Guiding Good Manufacturing Practices (GMP) in the Production and Trading of Health Supplements”. Documented traceability of the ingredients and suppliers is fundamental to the quality of finished products and should be made available. Where a pharmacopeial monograph is available, the ingredient should demonstrate compliance.

Since health supplements are classified as functional foods in Vietnam, they must comply with food safety regulations. Ingredients must be of at least food-grade quality with an appropriate quality management system in place (e.g., ISO 22000, HACCP, IFS).

3.2.2 Health Supplement Excipients

Health supplement excipients are considered food additives. As specified in Circular 24/2019 “Management and Use of Food Additives”, Vietnam adopts the use of food additives in accordance with the Codex General Standard for Food Additives (GSFA). Any additives subject to the provisions of the standard must be of appropriate food-grade quality, prepared and handled in the same way as a food ingredient.

They should at all times conform with the applicable specifications of identity and purity recommended by the Codex Alimentarius Commission or, in the absence of such specifications, with appropriate specifications developed by responsible national or international bodies.

3.2.3 Premixes

Premixed ingredients must comply with the safety and quality requirements above. Excipient premixes must only contain permitted food additives, and the mixture must not cause harm to human health. In cases where a new product with new effects is created, such effects, intended users and dose must be proven.

3.3 Ingredients for Veterinary Products

The Decree on Guidelines for the Law of Veterinary Medicine (No. 35/2016/ND-CP) states that a system of GMP must be in place for the manufacture of veterinary drugs in Vietnam that is compliant with the ASEAN GMP or WHO GMP standards for medicinal products, or a system at least equivalent to the ASEAN GMP standards. Therefore the GMP requirements for APIs for veterinary products are in line with these international regulations.

Quality standards of ingredients are specified in the Vietnamese pharmacopeia or international references as listed in Section 3.1.1 above.