In which cases must clinical drug testing be inspected?

16:07, 11/07/2024

On October 29, 2018, the Ministry of Health issued Circular 29/2018/TT-BYT regulating clinical drug trials.

According to Circular 29, the evaluation, inspection, and checking of compliance with Good Clinical Practice (GCP) are carried out in the following cases:

- The initial evaluation is conducted together with the issuance of a certificate of eligibility for pharmaceutical business for the pharmaceutical trial service provider. For clinical trial facilities specified in Point c, Clause 1, Article 2 of Circular 29, the initial evaluation is conducted when the facility implements clinical trial activities.- The periodic evaluation of maintaining GCP compliance is conducted every 3 years from the date of the evaluation report of the previous evaluation.- The ad-hoc evaluation of GCP compliance is conducted as prescribed in Clause 1, Article 15 of Circular 29.

See more principles of Good Clinical Practice in Circular 29/2018/TT-BYT, effective from January 1, 2019.

- Thanh Lam -

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