TO PROMULGATE A SET OF PRINCIPLES OF GOOD CLINICAL PRACTICE
The Ministry of Health issues the Circular No. 29/2018/TT-BYT on clinical trial of drugs on October 29, 2018.
Accordingly, trial facilities must apply Good Clinical Practice standard within 12 months in case of any change to infrastructure serving the trial or 06 months in case of another update, from the date on which the updated document is published on the web portal. Any provider of bioequivalence study services and bioequivalence study facility that fails to comply with Good Clinical Practice during the clinical trial must sign a contract or written agreement with a trial facility that complies with Good Clinical Practice.
Also in accordance with this Circular, the inspection of Good Clinical Practice compliance by a trial facility shall be carried out according to 03 degrees. First assessment is taken when issuing the certificate of eligibility for pharmacy business. Inspection of Good Clinical Practice compliance shall be periodically carried out every 03 years. In some specific case, facility shall be unscheduled inspected.
This Circular takes effect on January 01, 2019.
