The Resolution prescribes a number of special mechanisms and policies for grant of certificates of registration for marketing authorization of COVID-19 treatment drugs and vaccines manufactured in Vietnam as follows:
- With respect to domestically-manufactured COVID-19 treatment drugs and vaccines that are undergoing clinical trials, if the results of the phase-3 mid-term evaluation of these drugs’ safety and therapeutic efficacy or these vaccines’ protective efficacy based on their immunogenicity data have been obtained, they may be used for considering the conditional certification of registration for marketing authorization after:
+ Consultation with the National Ethics Committee in Biomedical Research for drugs and vaccines undergoing clinical trials in Vietnam;
+ Consultation with the Advisory Council on issuance of certificates of marketing authorization of drugs and medicinal ingredients for specific drugs or vaccines with reference to the guidance or recommendations of the World Health Organization (WHO).
- Further monitoring of safety, efficacy and management of recipients, number of doses and scope of administration of drugs and vaccines are required after certificates of registration for marketing authorization of these drugs and vaccines are granted.
In addition to the aforesaid regulations, any other regulations related to registration for marketing authorization of drugs and vaccines for prevention and control of Covid-19 disease must be subject to law.
For more details, please read the Resolution No. 86/NQ-CP dated August 6, 2021.
>> CLICK HERE TO READ THE ARTICLE IN VIETNAMESE
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