Evaluation Dossier for Bioequivalence Study Facility of Drugs 2020

Dossier for assessing bioequivalence trial establishments of drugs 2020 (illustrative image)

Each bioequivalence trial establishment of drugs will have different dossiers to assess the eligibility of the bioequivalence trial establishments of drugs, specifically regulated in Article 2 of Circular 10/2020/TT-BYT:

Firstly, establishments under the cases specified at point a, clause 3, Article 1 of this Circular shall submit 01 dossier as follows:

- Dossier as prescribed in Article 5 of Circular 04/2018/TT-BYT for the assessment of GLP compliance and the dossier as prescribed in Article 8 of Circular 29/2018/TT-BYT for the assessment of GCP compliance. In case the establishment has been granted a GLP Certificate or an evaluation report concluding the establishment meets GLP compliance, the establishment shall submit a dossier as prescribed in Article 8 of Circular 29/2018/TT-BYT for the request for GCP compliance assessment.

- In case the establishment has been granted GLP, GCP Certificate or an evaluation report concluding the establishment meets GLP, GCP compliance, the establishment only needs to submit an Application for a Certificate of Eligibility for Pharmacy Business according to the form specified in Clause 1, Article 32 of Decree 54/2017/ND-CP dated May 8, 2017 of the Government of Vietnam detailing and guiding the implementation of a number of articles and measures to enforce the Pharmaceutical Law (for establishments providing bioequivalence trial services for drugs), in which the content must clearly state that the establishment has been granted a GLP, GCP Certificate or an evaluation report concluding the establishment meets GLP, GCP compliance. For non-commercial bioequivalence drug trial establishments, an Application to conduct bioequivalence trials of drugs according to Form No. 01 issued with this Circular is only required.

- Establishments under the cases specified at point b, clause 3, Article 1 of this Circular shall submit 01 dossier as prescribed in Article 5 of Circular 04/2018/TT-BYT (for establishments requesting assessment for GLP compliance) or an Application as prescribed at point b, clause 1 of this Article (for establishments that have been granted a GLP Certificate) and the following technical documents:

+ A contract with a medical examination and treatment establishment that meets GCP for phase 1 of the clinical drug trials;

+ A copy of the GCP Certificate for phase 1 of the affiliated establishment or an evaluation report concluding the affiliated establishment meets GCP compliance for phase 1.

Secondly, establishments under the cases specified at point c, clause 3, Article 1 of this Circular shall submit 01 dossier as prescribed in Article 5 of Circular 04/2018/TT-BYT (for establishments requesting assessment for GLP compliance) or an Application as prescribed at point b, clause 1 of this Article (for establishments that have been granted a GLP Certificate) and the following technical documents:

- A list of facilities, equipment, and emergency means of the bioequivalence trial establishment of drugs;

- A contract with a medical examination and treatment establishment that meets GCP;

- A copy of the GCP Certificate of the affiliated establishment or an evaluation report concluding the affiliated establishment meets GCP compliance.

Refer to the full text of Circular 10/2020/TT-BYT effective from August 10, 2020.

Thu Ba

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