The Drug Administration of Vietnam notes that the selection of control drugs for bioequivalence study for drugs registration must comply with Circular No. 08/2010/TT-BYT and these principles:
1. It is prioritized to select an invention drug that is circulating in Vietnam as a control drug or it may use an invention drug that has been licensed and is being circulated in one of the member countries of international Conference on harmony (ICH).
2. In case the study used control drug being invention drug but the invention drug is not being circulated in Vietnam, the registration establishment is required to provide data demonstrating the ability to replace each other between the drug which has been used for study and the drug which is being circulated in Vietnam according to the regulations at clause 1 Article 5 of Circular No. 08/2010/TT-BYT .
3. Shipment of the control drug used for bioequivalence study and shipment of the control drug used for study demonstrating the ability to replace each other at point 2 above is not required the same shipment.
|Published||Vietlaw's Newsletter No. 558|