Vietnam: Application of pharmacopeia to test the quality of herbal ingredients/traditional drugs

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, the quality of herbal ingredients/traditional drugs must be governed and guaranteed according to the quality standards for herbal ingredients/traditional drugs specified in the pharmacopeia or internally applied standards of manufacturers.

Specifically, application of pharmacopeia is as follows:

1. Application of Vietnam’s pharmacopoeia and reference pharmacopoeias:

- Facilities trading in herbal ingredients/ traditional drugs are allowed to apply Vietnam's pharmacopoeia or one of the following reference pharmacopoeias: Chinese pharmacopoeia, Hong Kong pharmacopoeia, Japanese pharmacopoeia, Korean pharmacopoeia, Indian pharmacopoeia, international pharmacopoeias, European pharmacopoeia, British pharmacopoeia and U.S. pharmacopoeia;

- The application of standards of the pharmacopoeias mentioned in Point a hereof must include the application of all regulations on quality indices, quality levels and testing methods laid down in the corresponding treatises for herbal ingredients/ traditional drugs of the applicable pharmacopoeia and common quality indices, quality levels and testing methods laid down in its Annexes;

- Where an importer of herbal ingredients/ traditional drugs into Vietnam applies Vietnam’s pharmacopoeia in which quality standards are lower than the corresponding standards of a certain reference pharmacopoeia, the quality standards in the reference pharmacopoeia shall apply;

- If a manufacturer applies Vietnam’s pharmacopoeia or one of the reference pharmacopoeias specified in Point a hereof as announced but employs a testing method other than the one specified in the specific treatise for herbal ingredients/traditional drugs of the applicable pharmacopoeia, it is required to prove the equivalence of these two testing methods. Testing results obtained by adopting the testing method specified in the pharmacopoeia shall be used as the basis for evaluating quality of herbal ingredients/traditional drugs.

2. Application of other foreign pharmacopoeias:

If an establishment trading in herbal ingredients/ traditional drugs applies a pharmacopoeia other than the ones specified in Point a Clause 1 Article 5 of Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, the applied quality standards must:

- meet quality index and level requirements prescribed in the corresponding quality standard treatises of Vietnam’s pharmacopoeia or one of the reference pharmacopoeias mentioned in Point a Clause 1 Article 5 of this Circular; and

- common testing methods applied must be conformable with corresponding common testing methods specified in Vietnam’s pharmacopoeia or one of the reference pharmacopoeias mentioned in Point a Clause 1 Article 5 of this Circular.

Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from June 30, 2018.

- Thanh Lam -

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