Dossier for Approval of Bioequivalence Study of Drugs

08:57, 10/07/2024

Recently, the Minister of Health issued Circular 10/2020/TT-BYT Regulation on bioequivalence testing of drugs.

This Circular stipulates the dossier for requesting the approval of bioequivalence studies of drugs, including:

- Application for approval of bioequivalence studies of drugs by the bioequivalence testing institution submitted to the Institutional Ethics Committee in biomedical research;- Information dossier on the drug undergoing bioequivalence study including research materials on the drug;- Legal dossier of the drug undergoing bioequivalence study;- Research proposal for the bioequivalence study of the drug;- Scientific resume and a copy of the certificate of completion of a Good Clinical Practice course, and safety reporting practices of the principal investigator;- Information provision document and informed consent form for participants in the drug bioequivalence study;- Test drug label including information: drug name, active ingredient name, concentration/content, dosage form, batch number, expiration date, name, and address of the manufacturer.

For details, see Circular 10/2020/TT-BYT effective from August 10, 2020.

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