Procedure for Assessing the Facility's Eligibility for Bioequivalence Testing of Drugs

Procedure for evaluating facilities that meet the requirements for bioequivalence testing of drugs (illustrative image)

Specifically, in Article 3 Circular 10/2020/TT-BYT, it is stipulated that bioequivalence testing facilities of drugs must submit one set of documents corresponding to the cases specified in Article 2 of this Circular along with the appraisal fee to the Drug Administration of Vietnam, Ministry of Health.

Procedures for evaluating the facilities that meet the requirements for bioequivalence testing of drugs with each bioequivalence testing facility:

For facilities under the provisions of point a, clause 3, Article 1 of this Circular:

- The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to simultaneously evaluate compliance with GLP and GCP according to the procedures stipulated in Circular 04/2018/TT-BYT and/or Circular 29/2018/TT-BYT.

- In the case where the bioequivalence testing facility of drugs has already obtained a GLP Certificate or an assessment report confirming compliance with GLP, the Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to conduct a GCP evaluation according to the procedures stipulated in Circular 29/2018/TT-BYT.

- In cases where the bioequivalence testing facility of drugs has already obtained GLP and GCP Certificates or an assessment report confirming compliance with GLP, GCP: The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to receive and evaluate the documentation of the requesting facility.

For facilities under the provisions of point b, clause 3, Article 1 of this Circular:

- For facilities that have not obtained a GLP Certificate or an assessment report confirming compliance with GLP: The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to conduct the GLP compliance evaluation according to the procedures stipulated in Circular 04/2018/TT-BYT.

- For facilities that have already been issued a GLP Certificate or an assessment report confirming compliance with GLP: The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to receive and evaluate the documentation of the requesting facility.

For facilities under the provisions of point c, clause 3, Article 1 of this Circular:

- For facilities that have not obtained a GLP Certificate or an assessment report confirming compliance with GLP: The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to conduct GLP compliance evaluation and evaluation of the areas for drug users' accommodation and monitoring for bioequivalence testing according to the procedures stipulated in Circular 04/2018/TT-BYT.

- For facilities that have already been issued a GLP Certificate or an assessment report confirming compliance with GLP: The Drug Administration of Vietnam cooperates with the Department of Science, Technology and Training to evaluate the areas for accommodation and monitoring of drug users for bioequivalence testing of drugs, and the emergency facilities at the facility within 15 days from the date of receipt of complete and valid documentation.

See more related regulations in Circular 10/2020/TT-BYT effective from August 10, 2020.

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