Bioequivalence Study Dossier of the Drug from August 10, 2020

According to Circular 10/2020/TT-BYT, the dossier for bioequivalence studies of drugs is a technical dossier that includes the registration dossier for drug bioequivalence studies, the dossier requesting approval for drug bioequivalence studies, and the dossier requesting approval for the results of drug bioequivalence studies, specifically defined as follows:

Drug bioequivalence study dossier from August 10, 2020 (illustrative image)

Firstly, the registration dossier for bioequivalence studies of drugs includes:

- An application for conducting drug bioequivalence studies according to Form No. 03 issued with this Circular;

- Information dossier about the drug for bioequivalence studies: drug name, active ingredient name, composition, concentration/strength, dosage form, and other relevant information (if any).

Secondly, the dossier requesting approval for drug bioequivalence studies includes:

- An application for approval of drug bioequivalence studies from the drug bioequivalence study facility submitted to the Institutional Review Board in biomedical research according to Form No. 04 issued with this Circular;

- Information dossier about the drug for bioequivalence studies including research materials about the drug: formulation composition, source of raw materials, summary production schematic/process, drug quality standards, drug testing sheets (testing sheets from manufacturers that meet Good Manufacturing Practices (GMP) or from drug testing facilities that meet Good Laboratory Practices (GLP)), pharmaceutical development materials/dossiers of the drug for bioequivalence studies;

- Legal dossier of the drug for bioequivalence studies including:

+ Approved package insert of the reference listed drug used in the studies and the drug for bioequivalence studies (if any);

+ Research collaboration contract for drug bioequivalence studies between the entity having the drug for bioequivalence studies and the drug bioequivalence study facility; collaboration contract between the organization or individual having the drug and the research support organization (if any).

- Research protocol for bioequivalence studies of the drug, including:

+ Detailed explanation of the research protocol for bioequivalence studies of the drug;

+ Information collection form or Case Report Form (CRF);

- Principal investigator’s scientific CV and a copy of the certificate of completion of Good Clinical Practice (GCP) training, safety report practice, issued by the Ministry of Health or institutions authorized for GCP training;

- Information sheet provided to study participants and the consent form for participation in the drug bioequivalence study;

- Label of the drug for testing including information: drug name, active ingredient name, concentration/strength, dosage form, batch number, expiration date, name and address of the manufacturer. In cases where the drug already has a circulation registration certificate, its label should comply with Circular 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health on drug labeling and raw materials for drug production.

Thirdly, the dossier requesting approval for the results of drug bioequivalence studies includes:

- An application for approval of the results of drug bioequivalence studies according to Form No. 05 issued with this Circular;

- Report on the results of drug bioequivalence studies.

More details can be found in: Circular 10/2020/TT-BYT, which is effective from August 10, 2020.

Thu ba

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE