Circular No. 29/2018/TT-BYT dated October 29th, 2018 of the Ministry of Health on clinical trial of drugs
This Circular provides for promulgation and application of Good Clinical Practice; Good Clinical Practice (GCP) compliance assessment and applications and procedures for clinical trial of drugs. read more
GCP is a set of principles and standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
Regulated entities are providers of clinical trial services and providers of bioequivalence study services.
This Circular takes effect from January 1st, 2019.
To abolish Articles 2, 3, 4 Chapter III, Chapter IV, Chapter V, Chapter VI, Chapter VII, Chapter VIII, Articles 39, 40 of Circular No. 03/2012/TT-BYT dated February 2nd, 2012 and Decision No. 799/QD-BYT dated March 7th, 2008.
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