Chapter II
REQUIREMENTS FOR CLINICAL DATA TO ENSURE SAFETY AND EFFECTIVENESS, ELIGIBILITY FOR EXEMPTION FROM ONE OR MORE THAN ONE CLINICAL TRIAL PHASE, AND VACCINES REQUIRING PHASE 4 CLINICAL TRIAL IN VIETNAM
Article 11. Regulations on clinical data in applications for vaccine marketing authorization
1. Requirements for clinical data for safety and effectiveness assurance in applications for vaccine marketing authorization are provided in Points a and b Clause 1 Article 13 of Circular No. 32/2018/TT-BYT.
2. For vaccines manufactured at a manufacturing site or manufacturing facility different from where vaccines used in the clinical trial are manufactured, applicants may use clinical data of vaccines used in the clinical trial and shall prove that the change of manufacturing site or manufacturing facility does not affect vaccine quality. If the applicant or manufacturing facility does not own clinical data or is not affiliated to the same corporation as the clinical data owner, clinical data must be used with permission from its owner.
After being granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further evaluating vaccine safety and immunogenicity on the target population in Vietnam during use according to guidelines of the Ministry of Health (Administration of Science Technology and Training) if the vaccine has not been authorized by a Strengthening Regulatory Authority (SRA) mentioned in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT.
3. For vaccines which are manufactured in Vietnam and undergoing clinical trials, if phase 3 interim assessment results for safety and protection effectiveness based on immunogenicity data are available, these results may be used to apply for conditional granting of marketing authorization based on advice of the national research ethics committee (for drugs and vaccines undergoing clinical trials in Vietnam) and advice of the advisory board for each vaccine and with reference to WHO guidelines or recommendations.
Vaccines granted marketing authorization in the abovementioned cases are subject to further monitoring of their safety, effectiveness, recipients, dosage and scope of use after they are granted marketing authorization.
After granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further clinical research and clinical data update in compliance with guidelines of the Ministry of Health (Administration of Science Technology and Training).
Article 12. Requirements for clinical data of vaccines granted marketing authorization in Vietnam upon revision of clinical data in approved vaccine registration applications
For vaccines granted marketing authorization in Vietnam, upon revision of clinical data in approved vaccine registration applications, applicants shall provide additional clinical data in compliance with regulations in Appendix II of Circular No. 32/2018/TT-BYT or ICH-CTD (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Common Technical Document (CTD)) or guidance of United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) or WHO.
Article 13. Exemption from one or more than one clinical trial phase when applying for marketing authorization
The Minister of Health may consider and decide to exempt vaccines not meeting the requirements mentioned in Clause 1 Article 11 herein from one or more than one clinical trial phase (including clinical data reduction or exemption) based on advice of the advisory board in any of the following cases:
1. The vaccine has been authorized by at least one country and has clinical data on its safety and effectiveness.
In case the pharmaceutical authority of the authorizing country is not one of the regulatory bodies mentioned in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT, after granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further assessing the vaccine’s safety and immunogenicity on the target population in Vietnam during use according to guidelines of the Ministry of Health (Administration of Science Technology and Training).
2. The vaccine is manufactured in Vietnam using transferred technology for one or more than one part of or the whole manufacturing process and, prior to the technology transfer, the vaccine has clinical data on safety and effectiveness and is authorized by at least one country.
Article 14. Cases requiring phase 4 clinical trial in Vietnam
Based on advice from the advisory board, vaccines granted marketing authorization but needing further safety and effectiveness assessment must undergo phase 4 clinical trial in Vietnam.
Tìm kiếm
Thông tư 11/2021/TT-BYT (Bản Word)