What is the procedure for conducting clinical trials?

16:09, 11/07/2024

Circular 29/2018/TT-BYT was issued by the Ministry of Health, stipulating regulations on clinical drug trials. The document takes effect from January 01, 2019.

According to Circular 29, the process for conducting clinical drug trials is as follows:

- Registration for clinical drug trial research;- Approval of clinical drug trial research, including initial approval and approval of changes during the implementation of the clinical drug trial;- Organization of the clinical drug trial implementation;- Approval of the clinical drug trial results.

Additionally, the dossier for registering clinical drug trial research is specified in Circular 29 as follows:

- Application for clinical drug trial research registration;- Dossier of research product information; preclinical research documents; clinical drug trial research documents from previous phases in Vietnamese or in English accompanied by a Vietnamese summary.

More details can be found in Circular 29/2018/TT-BYT, amending and supplementing Circular 03/2012/TT-BYT.

- Thanh Lam -

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