VNM/203
WTO/TBT
VN Vietnam
  • 01 - Generalities, Terminology, Standardization, Documentation
  • 13 - Environment and health protection, Safety
2021-09-26
2021-08-18

Drugs subject to bioequivalence study and requirements for bioequivalence studies dossiers in registration for marketing authorization in Vietnam

Draft Circular Regulating on drugs subject to bioequivalence study and requirements for bioequivalence studies dossiers in registration for marketing authorization in Vietnam (15 page(s), in Vietnamese)

The Circular regulates drugs subject to bioequivalence study and requirements for bioequivalence study dossiers registration for marketing authorization in Vietnam. The Circular applies to:

·         Generic containing active ingredients or dosage forms must have bioequivalence study reports when registering for marketing authorization in Vietnam;

·         Bioequivalence study dossiers of generic;

·        These guidelines in this Circular only apply to chemical drugs that have systemic effects after being absorbed into the body systemic circulation.