Cases for Exemption from One or Several Clinical Trial Stages for Covid-19 Vaccine Registration?
Based on Article 13 of Circular 11/2021/TT-BYT stipulating cases eligible for exemption from one or some stages of clinical vaccine trials during registration for circulation as follows:
Vaccines that do not meet the regulations in Clause 1, Article 11 of this Circular shall be considered for exemption from one or some stages of clinical trials (including exemption from providing clinical data) by the Minister of Health based on the advisory opinions of the Advisory Council for the issuance of drug circulation registration certificates for any of the following cases:
- Vaccines that have been licensed for circulation in at least one country globally and have clinical data on safety and efficacy.
In cases where the drug regulatory authority of the country that has granted the circulation license is not among the regulatory authorities specified in Clause 10, Article 2 of Circular 32/2018/TT-BYT, after being granted the circulation registration certificate, the registration facility must cooperate with the production facility to continue assessing safety and immunogenicity in the target population in Vietnam during usage as guided by the Ministry of Health (Department of Science, Technology and Training).
- Vaccines produced in Vietnam through technology transfer of one, some, or all production stages of the finished product, if the pre-technology transfer vaccine has clinical data on safety and efficacy that has been licensed for circulation in at least one country globally.
Respectfully!
