TITLE: The draft Circular amending and supplementing a number of articles of Circular No. 03/2012/TT-BYT of the Ministry of Health Guidelines for Clinical trials on Drugs (3 pages, in Vietnamese).
Ministry of Health
138 B Giang Vo, Ba DinhHanoi, Viet Nam
Tel.: (84-4) 38435666
Fax: (84-4) 32373236
1. Delete Clause 3 of Article 7 of Circular No. 03/2012/TT-BYT;
2. Article 20. Stages of clinical trial of pharmaceutical products of herbal origin of Circular No. 03/2012/TT-BYT is amended and supplemented in order to provide more details on purpose, sample size and evaluation in each stage and to define the criteria for exemption of clinical trial at certain stages.
Proposed date of adoption: to be determined
Proposed date of entry into force: 45 days after adoptionFinal date for comments: 60 days after notification date