Circular 10/2020/TT-BYT: Procedure for Bioequivalence Testing of Drugs

Process of Bioequivalence Testing of Drugs (Illustration)

According to Article 8 of Circular 10/2020/TT-BYT, the process of bioequivalence testing of drugs is carried out according to the provisions of Articles 100 and 101 of the Pharmaceutical Law. To be specific:

Step 1: Registering for bioequivalence research of the drug:

- The establishment with drugs requiring bioequivalence testing sends 01 dossier for registering bioequivalence research of the drug as stipulated in Clause 1, Article 7 of this Circular to the bioequivalence testing facility.

- The bioequivalence testing facility considers the proposal and signs a contract for bioequivalence testing of the drug with the establishment needing such testing.

Step 2: Approving bioequivalence research of the drug:

- The bioequivalence testing facility prepares 01 dossier as stipulated in Clause 2, Article 7 of this Circular and submits it to the institutional ethics committee in biomedical research.

- The institutional ethics committee in biomedical research organizes a meeting to evaluate the bioequivalence research protocol of the drug within 10 days from the date of receiving a complete dossier and issues a protocol evaluation report.

- Within 05 days from the date of the protocol evaluation report by the institutional ethics committee, the person responsible for the professional aspects of the bioequivalence testing facility approves the research protocol if it meets the requirements.

- In case the bioequivalence research protocol needs revision, the bioequivalence testing facility is responsible for completing the dossier within 20 days from the date of receiving the evaluation report requesting revisions. Beyond this deadline, the approval procedure for the research protocol must start over.

- Within 05 days from the date of receiving the revised protocol, the person responsible for the professional aspects of the bioequivalence testing facility approves the bioequivalence research protocol of the drug.

Step 3: Organizing the bioequivalence testing of the drug:

The bioequivalence testing facility conducts the stages of the bioequivalence study at the bioequivalence testing facility or other related units according to the approved research protocol.

Step 4: Acceptance and approval of bioequivalence testing results of the drug:

- The principal investigator responsible for the study submits 01 dossier requesting acceptance of bioequivalence testing results of the drug as stipulated in Clause 3, Article 7 of this Circular to the institutional ethics committee in biomedical research.

- Within 10 days from the date of receiving a complete dossier, the institutional ethics committee in biomedical research organizes a meeting and issues an acceptance report on the bioequivalence testing results, which must include conclusions such as meeting requirements, meeting with necessary corrections, or not meeting requirements.

- Within 05 days from the date of the acceptance report meeting safety and efficacy requirements by the institutional ethics committee, the person responsible for the professional aspects of the bioequivalence testing facility approves the bioequivalence research report of the drug.

- In case the acceptance report meets requirements but requires corrections, the bioequivalence testing facility completes the dossier within 25 days from the date of receiving the notification. Beyond this deadline, the approval procedure for bioequivalence testing results must start over.

- Within 05 days from the date of receiving the revised dossier according to the notification, the person responsible for the professional aspects of the bioequivalence testing facility approves the bioequivalence research report of the drug.

See the full text at: Circular 10/2020/TT-BYT effective from August 10, 2020.

Tuesday

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