Vietnam country card

1. Health authorities information:

  • Name: DAV-MoH VN (Drug administration of Vietnam):

       – Drugs, biologics, vaccines & cosmetic;
       – VFA- MoH VN (Vietnam Food administration): Food supplement;
       – DMEC- MoH VN (Department of Medical Equipment & Construction): Medical devices

2. Regulatory requirement:

  • Dossier format: ACTD, ICH-CTD for drugs, vaccines &biologics. (Cosmetic: Asean PIF. Medical device: Asean CSDT).
  • WHO CPP format: Yes. (FSC for cosmetics, medical devices, food supplement).
  • GMP declaration/site registration: mandatory
  • BABE: Local guideline, refer ASEAN, US FDA, EMA.
  • Stability: Zone IVb required, accelerated & long term.
  • QC testing/sample: required for vaccines, some biologics, food supplement. Medical devices, cosmetics, generic drug: No
  • Labelling: local regulations
  • Valid period of MA: 5 years for generic, renewal; 3 years for NCE, new drugs, vaccines & biologics; unvalidity for cosmetics, medical device, food supplement.