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
- Internal and external technical review capability: Eluavators from MoH VN
- Pre-submission meeting: Yes
- Websites: https://dav.gov.vn/; https://vfa.gov.vn/; https://dmec.moh.gov.vn/;
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.
