Regulations on procedures for the bioequivalence study for drug in Vietnam
According to the latest Vietnamese regulations, how does the procedures for the bioequivalence study for drug carry out?
Regulations on procedures for the bioequivalence study for drug in Vietnam (Image from the Internet)
According to Article 8 of Circular 10/2020/TT-BYT (Effective from August 10, 2020), the procedures for the bioequivalence study for drug are carried out as follows:
* Registration of the bioequivalence study:
- The facility that owns the drug undergoing the bioequivalence study shall submit 01 set of application for registration of bioequivalence study as prescribed in Clause 1 Article 7 hereof to the bioequivalence study facility.
- The bioequivalence study facility shall consider accepting the application and entering into a bioequivalence study service contract with the facility owning the drug.
* Approval for the bioequivalence study:
- The bioequivalence study facility shall prepare 01 set of application as prescribed in Clause 2 Article 7 hereof, and send it to the internal biomedical ethics committee.
- The internal biomedical ethics committee shall hold a meeting for inspection of the bioequivalence study outline within 10 days from receipt of an adequate application, and issue an inspection record.
- Within 05 days from the date on which the inspection record is given by the internal biomedical ethics committee, the person in charge of professional expertise of the bioequivalence study facility shall decide to give approval for the bioequivalence study outline if it is satisfactory.
- If the bioequivalence study outline needs to be modified, the bioequivalence study facility shall modify the bioequivalence study outline within 20 days from receipt of the inspection record given by the internal biomedical ethics committee. Over this period, procedures for approval for the bioequivalence study outline shall be repeated from the first step.
- Within 05 days from receipt of the complete bioequivalence study outline, the person in charge of professional expertise of the bioequivalence study facility shall give approval for the bioequivalence study outline.
* Conduct of the bioequivalence study:
The bioequivalence study facility shall carry out bioequivalence study phases at its own premises or relevant units according to the approved bioequivalence study outline.
* Assessment and approval for bioequivalence study result:
- The principal investigator shall submit 01 set of application for assessment of bioequivalence study result as prescribed in Clause 3 Article 7 hereof to the internal biomedical ethics committee.
- Within 10 days from receipt of an adequate application, the internal biomedical ethics committee shall hold a meeting for assessment of bioequivalence study result and give an assessment report indicating that the bioequivalence study result is satisfactory, partially satisfactory or unsatisfactory.
- Within 05 days from the date on which the internal biomedical ethics committee gives an assessment report indicating that the bioequivalence study result is satisfactory, the person in charge of professional expertise of the bioequivalence study facility shall give approval for the bioequivalence study report.
- If the assessment report indicates that the bioequivalence study result is satisfactory but needs modifications, the bioequivalence study facility shall complete the application within a maximum period of 25 days from receipt of written notification. Over this period, procedures for approval for the bioequivalence study result shall be repeated from the first step.
- Within 05 days from receipt of the complete application which has been modified as requested, the person in charge of professional expertise of the bioequivalence study facility shall decide to give approval for the bioequivalence study report.
Above are the entire procedures for the bioequivalence study for drug according to Circular 10/2020/TT-BYT (Effective from August 10, 2020).
Best regards!
