##  [Vietnam: Issuance & Renewal of Nearly 600 Drug Registrations](/mandate/vietnam-issuance-renewal-of-nearly-600-drug-registrations) 

December 6, 2025

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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Source

[https://moh.gov.vn/thong-tin-chi-dao-dieu-hanh/-/asset\_publisher/DOHhlnDN87WZ/c…](https://moh.gov.vn/thong-tin-chi-dao-dieu-hanh/-/asset_publisher/DOHhlnDN87WZ/content/bo-y-te-cap-moi-gia-han-gan-600-thuoc-trong-o-co-hang-chuc-thuoc-tuong-uong-sinh-hoc?inheritRedirect=false&redirect=https%3A%2F%2Fmoh.gov.vn%3A443%2Fthong-tin-chi-dao-dieu-hanh%3Fp_p_id%3D101_INSTANCE_DOHhlnDN87WZ%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Drow-0-column-2%26p_p_col_count%3D1)

<https://moh.gov.vn/thong-tin-chi-dao-dieu-hanh>

<https://moh.gov.vn/>

 

 

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