Criteria for determining a traditional drug fully exempt from clinical trial in Vietnam

According to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, criteria for determining a traditional drug fully exempt from clinical trial in Vietnam are specified as follows:

1. Prepared traditional medicinal materials.

2. Traditional drug recognized by the Ministry of Health and meeting one of the following criteria:

- The traditional drug is an old remedy;

- The hereditary remedy has been granted a certificate as prescribed by law, has effects and indications that clearly show the traditional drug condition and has its finished products commissioned in writing by the Science and Technology Committee or Ethics Committee for Traditional drug of provincial level or higher upon their sale to ensure the safety and efficacy.

- The drug that has been used to give treatment to at least 200 (two hundred) patients at a traditional drug facility of provincial level or higher for at least 10 (ten) years by the time of submitting the marketing application has stable administration route, dose, manufacturing process and dosage form, has effects and indications that clearly show the traditional drug condition and has its safety and efficacy commissioned in writing by the Science and Technology Committee or Ethics Committee for Traditional drug of provincial level or higher;

- The traditional drug has been fully exempt from clinical trial, has its dosage form changed but does not have its ingredients, concentration, indications, effects and administration route changed, and has its clinical safety and efficacy commissioned in writing by the Science and Technology Committee or Ethics Committee for Traditional drug of provincial level or higher to serve disease treatment according to the original remedy;

- …

3. The traditional drug has been granted a certificate of marketing authorization before the effective date of the Law on Pharmacy of Vietnam, except in the cases mentioned in Clause 3 Article 8 and Clause 2 Article 9 of this Circular.

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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