Vietnam: Cases in which a traditional drug whose safety and efficacy still has to be monitored

Nguyen Trinh

10:51, 09/10/2018

Recently, the Ministry of Health of Vietnam has issued Circular No. 21/2018/TT-BYT on marketing authorization of traditional drugs and herbal materials.

According to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, the traditional drugs whose marketing authorization is applied for and safety and efficacy still has to be monitored include:

- The traditional drugs that contain toxic herbal materials on the list of toxic herbal materials derived from minerals in the Appendix III and toxic herbal materials not starred (*) on the list of toxic herbal materials derived from plants and animals in the Appendix I and Appendix II enclosed with the Circular No. 42/2017/TT-BYT;

- The traditional drugs that do not have sufficient clinical data about drug safety and the traditional drugs that are exempt from certain phases of clinical trial.

Moreover, the traditional drugs whose marketing authorization is applied for still have to have its safety and efficacy monitored if there is not sufficient clinical data about the safety and efficacy in accordance with regulations on clinical trial. The certificate of marketing authorization of the traditional drugs is valid for 03 years.

Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from October 28, 2018.

- Thanh Lam -

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