New Text Notification

Vietnam: Order of priority for selection of comparator products used in bioequivalence testing

Võ Ngọc Nhi

17:32, 07/09/2022

The Minister of Health of Vietnam issues Circular 07/2022/TT-BYT September 5, 2022 prescribing medical products subject to bioequivalence testing and requirements for bioequivalence research data reports in registration of medical product circulation in Vietnam.

Specifically, the order of priority for selection of comparator product used in bioequivalence testing for circulation registration is as follows:

(1) Medical products on the Ministry of Health's list of original brand-name medical products or medical products granted circulation registration certificates by the Ministry of Health of Vietnam with full data on quality, safety, and clinical efficacy;

(2) Comparator product is an innovator pharmaceutical product that has not yet been granted a certificate of circulation in Vietnam but has been approved by one of the drug administration agencies specified in Clause 10, Article 2 of Vietnam's Circular 32/2018/TT-BYT and is being circulated in the markets of these countries;

(3) In the event that it is not possible to identify a comparator product that meets these criteria (1), (2), the preference for the selection of a control drugs is as follows:

- The medical product has been approved by one of the drug administration agencies specified in Clause 10, Article 2 of Vietnam's Circular 32/2018/TT-BYT and is being circulated in the markets of these countries.

- The medical product has been prequalified by the World Health Organization.

Among the medical products that meet this condition, priority is given to those with a valid circulation registration certificate issued by the Vietnamese Ministry of Health of Vietnam.

Vietnam's Circular 07/2022/TT-BYT takes effect from November 1, 2022.

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