The Ministry of Health (Vietnam) has issued and renewed nearly 600 drugs and pharmaceutical ingredients, including 98 bioequivalent drugs, to support treatment needs and strengthen regulatory oversight.
Key Highlights:
- Registrations Issued/Renewed: Nearly 600 products granted or renewed certificates.
- Breakdown:
- 404 domestically manufactured drugs newly approved
- 42 domestic drugs renewed (26 for 5 years, 14 for 3 years)
- 98 bioequivalent drugs listed
- Compliance Requirements:
- Products must follow registered dossiers and display official registration numbers
- Manufacturers must ensure full compliance with all MoH regulations
- Facilities must maintain operational standards through certificate validity
- Additional Obligations:
- Update labels/leaflets within 12 months for renewed registrations (Circular 01/2018/TT-BYT)
- Monitor drug safety, effectiveness, and report adverse events
- Product Range:
- Includes treatments for respiratory diseases, cardiovascular disorders, diabetes, cancer, infections, pain, inflammation, and various bioequivalent formulations
This update reinforces Vietnam’s commitment to product quality, safety, and regulatory compliance.
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