What are criteria for determining a traditional drug fully exempt from clinical trial in Vietnam?

What are criteria for determining a traditional drug fully exempt from clinical trial in Vietnam?

Pursuant to Article 7 of the Circular 21/2018/TT-BYT (amended by Clause 10 Article 1 of the Circular 39/2021/TT-BYT) stipulating criteria for determining a traditional drug fully exempt from clinical trial in Vietnam as follows:

1. Traditional drugs subject to exemption from clinical trials under recognition of the Ministry of Health shall include the drugs with the origin or formulation in the following cases:

a) Traditional ingredient;

b) Ancient remedy;

c) Home remedy which has been granted the certificate of home remedy according to the provisions of the law with the effects and indications that include their description in traditional medicine language and tested for acute toxicity and semi-chronic toxicity in order to ensure safety and effectiveness.

d) Traditional drugs that have been exempted from clinical trials with change in the dosage form without change in composition, content, indications, effects and the method of use; tested for acute and semi-chronic toxicity to ensure safety and effectiveness;

dd) Dose-adjusted remedy with the documents and data that prove or analyze, justify the dose-adjustment in accordance with the theory of traditional medicine. In case of dose-adjustment, if the ingredients contains herbal ingredients on the list of the toxic herbal ingredients promulgated by the Minister of Health, the acute and semi-chronic toxicity shall be tested to ensure safety and effectiveness;

e) Products of the provincial and equivalent scientific research projects on traditional drugs that have been accepted by the scientific council of the province and decided by the People's Committee of province, or approved by the appropriate Ministry according to applicable regulations. The products have effects, indications that include their description in traditional medicine language and have been tested for acute and semi-chronic toxicity, pharmacological effects in order to ensure safety and effectiveness, except for the cases specified in Article 10 of this Circular;

g) Traditional drugs with indications according to the data on clinical research under the regulations on clinical trials of the Ministry of Health, which have been granted marketing authorization and marketed for more than 10 years without detection of harmful effects and adverse reactions of drugs; or traditional drugs without the data on clinical research which have been granted marketing authorization and marketed for more than 5 years without detection of harmful effects and adverse reactions of drugs or traditional drugs;

h) Dose-adjustment from the remedies that have been granted marketing authorization and marketed on the market for 5 years or more, except for traditional drugs with indications according to the data on clinical research under regulations on clinical trials of the Ministry of Health without detection of harmful effects and adverse reactions of drugs; have the documents and data that prove or analyze and justify the reduction in accordance with the theory of traditional medicine.

2. Traditional drugs that are extended from drugs which have been granted marketing authorizations before the effective date of the Law on Pharmacy No. 105/2016/QH13, except for drugs subject to clinical trials of the Advisory Council for issuance of marketing authorization of traditional drugs and herbal ingredients in case of detection of harmful effects adverse reactions of drugs in circulation.

What are criteria for determining a traditional drug exempt from certain phases of clinical trial in Vietnam?

Pursuant to Article 8 of the Circular 21/2018/TT-BYT (amended by Clause 11 Article 1 of the Circular 39/2021/TT-BYT) stipulating criteria for determining a traditional drug exempt from certain phases of clinical trial in Vietnam as follows:

The traditional drugs shall undergo phase 3 clinical trials without undergoing from phase 1 and phase 2 clinical trials in Vietnam if the drugs meet one of the following criteria:

1. The drugs subject to exemption from clinical trials have change or addition to their indications according to the main effects of the drugs without change in the composition of the drug formulation, dosage or dosage form;

2. The home remedy which has been granted the certificate of home remedy according to the provisions of law fails to satisfy the provisions of Point c, Clause 1, Article 7 of this Circular;

3. The drugs which have been used for treatment at medical facilities with traditional medicine (grade II or higher) have the fixed method of use, dosage, process and dosage form; have effects, indications that include their description in traditional medicine language; have been tested for acute and semi-chronic toxicity, pharmacological effects in order to ensure safety and effectiveness and approved by the Scientific Council of the medical facilities.

What are criteria for determining a traditional drug required to undergo phase 4 of clinical trial in Vietnam?

Pursuant to Article 9 of the Circular 21/2018/TT-BYT stipulating criteria for determining a traditional drug required to undergo phase 4 of clinical trial in Vietnam as follows:

A traditional drug that has been granted a certificate of marketing authorization is required to undergo phase 4 of clinical trial in Vietnam if one of the following criteria is satisfied:

1. Additional information is provided to serve the assessment of safety and efficacy of the drug at the request of a pharmacy authority.

2. The traditional drug that has been granted the certificate of marketing authorization before the effective date of the Law on Pharmacy No.105/2016/QH13 is required to undergo phase 3 of clinical trial at the request of the Advisory Council if its ingredients fail to comply with Clause 2 Article 7 of this Article, and contraindications and adverse effects other than those specified in the package insert of the drug granted the certificate of marketing authorization are not found.

3. The traditional drugs mentioned in Article 8 of this Circular are yet to undergo phase 4 of clinical trial in Vietnam.

What are criteria for criteria for determining a traditional drug required to undergo all phases of clinical trial in Vietnam?

Pursuant to Article 10 of the Circular 21/2018/TT-BYT (amended by Clause 12 Article 1 of the Circular 39/2021/TT-BYT) stipulating criteria for criteria for determining a traditional drug required to undergo all phases of clinical trial in Vietnam as follows:

Criteria for identification of traditional drugs subject to the testing in all stages in the following cases: New traditional drugs specified at Point a, Clause 1, Article 89 of the Law on Pharmacy.

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