Criteria for exemption of clinical trial in Vietnam before marketing authorization in Vietnam

Criteria for exemption of clinical trial in Vietnam before marketing authorization(Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Criteria for exemption of clinical trial in Vietnam before marketing authorization

Criteria for exemption of clinical trial in Vietnam before marketing authorization under Article 20 of Circular 08/2022/TT-BYT are as follows:

- A generic drug has the same active ingredients, content and concentration thereof, route of administration, uses, doses, indications, intended users and dosage form as those of another drug that has been granted marketing authorization.

- A new drug (except vaccines), has been granted marketing authorization in at least another country and has sufficient clinical data about its safety and efficacy according to Article 13 and Article 18 of Circular 08/2022/TT-BYT.

- A herbal drug has been granted the marketing authorization before the effective date of the Law on Pharmacy 2016 and has indications which do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam.

- A vaccine satisfies the requirements in Point d Clause 4 Article 22 of Circular 08/2022/TT-BYT, all of the manufacturing processes of which are carried out in the country of one of the regulatory authorities specified in Clause 9 Article 2 of Circular 08/2022/TT-BYT, and the clinical data for its safety and efficacy is sufficient according to Article 13 of Circular 08/2022/TT-BYT.

2. Criteria for exemption of one or some stages of clinical trial of herbal drugs before marketing authorization in Vietnam

According to Article 19 of Circular 08/2022/TT-BYT stipulating the criteria for exemption of one or some stages of clinical trial of herbal drugs before marketing authorization is as follows:

In one of the following cases, the Minister of Health of Vietnam is entitled to exempt one or several stages of clinical trial (including clinical data) of a herbal drug that fails to meet the requirements in Article 18 of Circular 08/2022/TT-BYT on the basis of opinions given by the Advisory Board:

- The drug is meant to serve urgent needs for national defense and security, epidemic control, disaster recovery and cannot be replaced by any other drug on the market.

- The drug has been granted marketing authorization by at least one of the regulatory authorities specified in Clause 9 Article 2 of Circular 08/2022/TT-BYT according to the reduced clinical documents they require.

- The drug is meant to treat a disease on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy 2016 but is not exempt from clinical trial as prescribed in Clause 3 Article 20 of Circular 08/2022/TT-BYT.

- The drug is new combination of herbal ingredients that have been used in Vietnam and its indications do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy 2016.

3. Mandatory clinical data in an application for marketing authorization a herbal drug in Vietnam

The mandatory clinical data in an application for marketing authorization a herbal drug according to Article 18 of Circular 08/2022/TT-BYT are as follows:

- Mandatory clinical data for assurance of safety and efficacy in the application for marketing authorization of a new herbal drug

+ Clinical studies of the drug, data in clinical documents shall be conformable with guidelines for preclinical and clinical studies of herbal drugs of the Ministry of Health of Vietnam or other organizations recognized by Vietnam, including:

Research guidelines for evaluating the safety and efficacy of herbal medicines or guidelines of regulatory authorities specified in Clause 9 Article 2 of Circular 08/2022/TT-BYT.

If the study is carried out before the effective date of the aforementioned regulations or guidelines, data of such study is acceptable;

+ Data extracted from the following documents is acceptable as clinical data for consideration of safety and efficacy of a herbal drug:

++ The treatises about safety and efficacy of the drug mentioned in pharmacopoeias or drug formularies of Vietnam and other countries;

++ Evaluations of safety and efficacy of the drug published on SCI (Science Citation Index) journals and clinical data collected from other medical publications;

++ Evaluations of safety and efficacy in a national, ministerial or provincial research which has been accepted.

- Clinical data is not required as prescribed in Clause 1 of Article 18 of Circular 08/2022/TT-BYT if the herbal drug satisfies one of the following requirements:

+ The drug has the same composition, content of herbal ingredients, indications and dosage form as those of another herbal drug which has been granted marketing authorization (even if it has expired), except traditional drugs the indications of which do not include any of the diseases on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy;

+ The drug has the same composition, content of herbal ingredients, indications and dosage form as those of another herbal drug which has been granted a new or extended marketing authorization in Vietnam for at least 05 years, has sufficient clinical data as prescribed in Clause 1 of this Article and is not meant to treat the diseases on the list of diseases published by the Minister of Health of Vietnam according to Point b Clause 1 Article 89 of the Law on Pharmacy.

Quoc Dat

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