Circular 10: Bioequivalence Testing Facilities for Drugs from August 10, 2020

In Clause 3 Article 1 of Circular 10/2020/TT-BYT, it is stipulated that the bioequivalence testing facilities for drugs subject to this Circular are facilities that meet the requirements regarding infrastructure, technology, and personnel as regulated at point g clause 1 Article 33 of the Pharmaceutical Law, including:

Bioequivalence testing facility for drugs from August 10, 2020 (illustrative image)

- The facility meets the principles and standards of Good Laboratory Practice (GLP) as specified in Circular 04/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health, stipulating Good Laboratory Practice and meets the principles and standards of Good Clinical Practice (GCP) for Phase 1 as specified in Circular 29/2018/TT-BYT dated October 29, 2018, issued by the Minister of Health.

- The facility meets GLP requirements as specified in Circular 04/2018/TT-BYT, does not have accommodation or monitoring areas for drug users serving the bioequivalence evaluation of drugs and has a contract linked with a clinical drug testing facility meeting GCP for Phase 1 of clinical drug testing as specified in Circular 29/2018/TT-BYT;

- The facility meets GLP requirements as specified in Circular 04/2018/TT-BYT, has accommodation and monitoring areas for drug users serving the bioequivalence evaluation of drugs, meeting the principles and standards of Good Clinical Practice as specified in the Appendix issued with this Circular and has a contract linked with a clinical drug testing facility meeting GCP as specified in Circular 29/2018/TT-BYT to conduct the clinical research phase in the bioequivalence testing of drugs.

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

Thu Ba

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