Vietnam Chamber of Commerce and Industry (VCCI) asks for comments to the Draft Circular regarding drugs to enforce BE test
District 7. On September 21st, 2021
CM Plus Vietnam would like to introduce the poll for the draft of a Circular regarding drugs to enforce Bio-equivalence (BE) test, in below:
Vietnam Chamber of Commerce and Industry (VCCI) asks for comments to the Draft Circular regarding drugs to enforce BE test
Currently, the Ministry of Health is developing a Draft Circular to replace Circular No. 08/2010/TT-BYT stipulating drugs that must be tested for bio-equivalence and requirements for bio-equivalence testing dossiers in registration.
The draft shall stipulate criteria for selection of which pharmaceutical substances subject to bio-equivalence testing; generic drugs of non-BE testing; regulations on retention drugs; regulations for bio-equivalence studies; bio-equivalence report dossier; application roadmap and transitional terms, terms of reference, etc.
Full text of the draft and Annexes have been posted on VCCI’s website http://vibonline.com.vn – (see Draft item).
Comments and suggestions are welcome by Oct 5th, 2021 and to be submitted to the following address (fax and/or email based comments are possible as well):
“Legal Department” VCCI – 9 Đào Duy Anh St., Đống Đa District, Hà Nội
Tel: 024.35770632/024.35742022 – Ext: 355; Fax: 024.35771459
Email: xdphapluat@vcci.com.vn/xdphapluat.vcci@gmail.com
See more info at the following links:
210915_CV lyk DTTT ve thuoc phai thu tuong duong sinh hoc
32-du-thao-phu-luc-thong-tu-be–04092021_1631063702 210915_CV lyk DTTT ve thuoc phai thu tuong duong sinh hoc
Source: Info from Vietnam Chamber of Commerce and Industry VCCI.