Vietnam Ministry of Health Updates Guideline on Registration of Drug and Medicinal Materials

Circular 08/2022/TT-BYT (Circular stipulating the registration of DRUG, Medicinal materials) was issued on 5th September 2022 and will be implemented on 20 Oct 2022, replacing the current guideline Circular 32/2018/TT-BYT dated 12 Nov 2018.

The Ministry of Health now accepts Certificate of Pharmaceutical product (CCP) that is issued by competent authorities in other countries that follows the WHO template.

The reference regulatory authorities are now consolidated from both reference authorities and the Stringent Regulatory authorities and any additional CCP from these authorities can be used as reference CCP.

Applicants can find proof of marketing status from any of these authorities if the product is not currently marketed in the manufacturer’ country.

Pursuant to the issue of Circular 08/2022/TT-BYT, the applicant of drug registration dossiers will bear full overall responsibilities to the Ministry of Health on any matters that are related to the drug licenses, which require only legal responsibility.

Since September 2018 when Circular 32/2018/TT-BYT was issued, foreign applicants have had difficulty obtaining the Certificate of Pharmaceutical product that fully followed Vietnam country-specific requirements. This new Circular removes this bottleneck and reduces the number of CPP required from competent authorities in case of reference.

More details can be found here:

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