On 21 August 2020, the Ministry of Health (MOH) issued Decision No. 3659/QD-BYT (Decision No. 3659), which guides research, clinical trials, registration for circulation, and use of the COVID-19 vaccine. Decision No. 3659 also took effect on the signing date (i.e., on 21 August 2020).
Decision No. 3659 regulates the following:
- COVID-19 vaccine research and quality verification
- COVID-19 vaccine clinical trials
- Assessment of compliance with good manufacturing practice standards
- COVID-19 vaccine circulation registration
- COVID-19 vaccine use and implementation
The noteworthy point of this Decision is the MOH’s permission to speed up the process of verifying and evaluating circulation registration to promote the research, development and production of the COVID-19 vaccine in the shortest time possible while still ensuring the principles of safety and efficiency for patients.
Fast-track procedure for circulation registration of COVID-19 vaccine
Since the COVID-19 vaccine is meant to serve the urgent need for epidemic control, the MOH may consider exempting one or several clinical trial phases, based on the recommendation of the Advisory Board.
Besides the standard requirements such as administrative, quality, pre-clinical and clinical documents, the MOH allows applicant to supplement the following time-consuming documents after submitting the registration application:
- Test report, quality standards and testing methods certified by the Institute of Vaccine and Medical Biologicals, which can be supplemented when the results are available.
- Study data of stability of active ingredients and finished products with registered expiry date, which can continue to be updated during the application review.
- Clinical trial results, which can continue to be updated during the application review.
In addition, the procedures for granting the marketing authorization of the COVID-19 vaccine must comply with the fast-track appraisal under Article 41 of Circular No. 32/2018/TT-BYT in order to shorten the administrative procedures and timeline while ensuring safety, quality and efficiency on the basis of a benefit/risk assessment.
Under the fast-track procedure, the Drug Administration of Vietnam shall issue the marketing authorization for the COVID-19 vaccine within six months from the date of receipt of a complete application, instead of 12 months under the normal procedure.