What are the quality standards of medicinal herbs and traditional medicines in Vietnam?
What are the quality standards of medicinal herbs and traditional medicines in Vietnam? What are regulations on application of the Vietnamese Pharmacopoeia and Pharmacopoeias of the world in the business of traditional medicines in Vietnam? What are the basic standards of medicinal herbs and traditional medicines in Vietnam?
What are the quality standards of medicinal herbs and traditional medicines in Vietnam?
Pursuant to Article 4 of Circular 38/2021/TT-BYT stipulating the quality standards of medicinal herbs and traditional medicines in Vietnam as follows:
1. Medicinal herbs and traditional medicines must apply quality standards according to pharmacopoeia or basic standards. The quality standards for medicinal herbs and traditional medicines are presented in Appendix I, Form 01 attached to this Circular.
2. Business establishments of medicinal herbs and traditional medicines must conduct the validation and evaluation of the testing methods that the establishment has announced to apply. The validation of standards and testing methods must be carried out at a testing facility that meets the Good Laboratory Practice for Drugs (GLP) standards or a testing service business establishment that has been granted a pharmaceutical business license.
3. The Ministry of Health (Department of Traditional Medicine Administration) organizes the validation of dossiers and approves the quality standards for medicinal herbs and traditional medicines according to the regulations on the registration of traditional medicines; regulations on the import license of medicinal herbs and traditional medicines that do not have a circulation permit; and regulations on the announcement of quality standards for medicinal herbs.
What are the quality standards of medicinal herbs and traditional medicines in Vietnam? - Source: Internet
What are regulations on application of the Vietnamese Pharmacopoeia and Pharmacopoeias of the world in the business of traditional medicines in Vietnam?
Pursuant to Article 5 of Circular 38/2021/TT-BYT stipulating application of the Vietnamese Pharmacopoeia and Pharmacopoeias of the world as follows:
Application of the Vietnamese Pharmacopoeia and pharmacopoeias of the world:
1. Business establishments of medicinal herbs and traditional medicines; medical facilities are allowed to apply the Vietnamese Pharmacopoeia or pharmacopoeias of the world, but the quality indicators and quality levels specified in the pharmacopoeia must not be lower than those of the Vietnamese Pharmacopoeia.
2. Business establishments importing medicinal herbs and traditional medicines into Vietnam must apply the pharmacopoeia of the exporting country. In cases where the quality indicators and quality levels specified in the pharmacopoeia of the exporting country are lower than those of the Vietnamese Pharmacopoeia, the Vietnamese Pharmacopoeia or the pharmacopoeia of the countries with quality indicators and quality levels specified in the pharmacopoeia higher than those of the Vietnamese Pharmacopoeia must be applied.
3. The application of the pharmacopoeia must apply all regulations on quality indicators, quality levels in the corresponding herbal and traditional medicine monographs and the general testing methods specified in that pharmacopoeia. The application of the testing methods in each monograph of drugs, excipients, and direct contact drug packaging listed in the pharmacopoeia is carried out on a voluntary basis.
4. In case the business establishment announces to apply the Vietnamese Pharmacopoeia or one of the pharmacopoeias of the countries in the world but uses a testing method other than the testing method listed in the separate monograph of the medicinal herb and traditional medicine in the pharmacopoeia that has been applied, it must prove the equivalence between the testing methods. The test results using the testing methods listed in the pharmacopoeia are the basis for concluding the quality of medicinal herbs and traditional medicines.
What are the basic standards of medicinal herbs and traditional medicines in Vietnam?
Pursuant to Article 6 of Circular 38/2021/TT-BYT stipulating the basic standards as follows:
Basic standards for medicinal herbs and traditional medicines developed and applied by the establishments must meet the requirements stipulated in point b, clause 2, Article 102 of the Law on Drugs 105/2016/QH13 (hereinafter referred to as the Law on Drugs), specifically as follows:
1. Meet the requirements for quality indicators and quality levels in the corresponding monographs of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries and the quality indicators, quality levels, and general testing methods specified in the Appendices of the Vietnamese Pharmacopoeia or pharmacopoeias of other countries in accordance with the provisions of Article 5 of this Circular.
2. In cases where the Vietnamese Pharmacopoeia, pharmacopoeias of other countries do not have corresponding monographs of medicinal herbs and traditional medicines, the establishment must develop standards based on the results of scientific research, the results of testing, evaluation, and analysis, or in accordance with the regulations of other foreign pharmacopoeias. The approval and announcement of the quality standards for medicinal herbs and traditional medicines are carried out in accordance with the provisions of clause 3, Article 4 of this Circular.
Best regards!
