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In Vietnam, the regulation of medicinal products, pharmaceutical drugs, biologicals, and vaccines is overseen by the Drug Administration of Vietnam (DAV), which operates under the Ministry of Health (MOH). DAV is the central Regulatory authority responsible for drug registration, marketing authorization, pharmacovigilance, GMP oversight, and post-approval Regulatory compliance for pharmaceutical products in Vietnam.

For global pharmaceutical companies, understanding the role of DAV and Vietnam’s Regulatory framework is essential for successful drug registration, lifecycle management, and market access.

Drug Administration of Vietnam (DAV): The Core Pharmaceutical Regulatory Authority

The Drug Administration of Vietnam (DAV) is the primary body regulating pharmaceutical Regulatory affairs in Vietnam. It governs the approval, importation, manufacture, distribution, and safety monitoring of medicinal products intended for human use.

Key Regulatory Responsibilities of DAV

  • Evaluation and approval of drug registration dossiers (CTD/ASEAN CTD format)
  • Issuance of Marketing Authorization (MA) for pharmaceutical products
  • Oversight of quality, safety, and efficacy of medicines throughout the product lifecycle
  • GMP compliance assessment and recognition of domestic and foreign manufacturing sites
  • Regulation of import/export permits for pharmaceutical products and APIs
  • Management of pharmacovigilance and adverse drug reaction (ADR) reporting
  • Review of labeling, package inserts, and promotional materials

DAV serves as the primary point of contact for Regulatory affairs professionals managing medicinal product approvals in Vietnam.

Legal Framework Governing Medicinal Products in Vietnam

Pharmaceutical regulation in Vietnam is governed by a structured legal framework that aligns increasingly with international and ASEAN regulatory standards.

Key Laws and Regulations

  • Law on Pharmacy (Law No. 105/2016/QH13) – The cornerstone legislation governing drugs and medicinal products
  • Government Decrees implementing the Law on Pharmacy, covering registration, importation, and distribution
  • MOH Circulars detailing technical requirements for:
    • Drug registration and variations
    • Classification of prescription and non-prescription medicines
    • Bioequivalence and clinical data requirements
    • Pharmacovigilance obligations

Recent Regulatory updates (2024–2025) have focused on streamlining drug registration procedures, improving transparency, and strengthening post-marketing surveillance, directly impacting Regulatory affairs strategies for 2025–2026.

Drug Registration and Regulatory Affairs Pathway in Vietnam

For pharmaceutical companies, drug registration in Vietnam involves a structured Regulatory process managed by DAV:

  1. Product classification and Regulatory pathway determination
  2. Appointment of a locally licensed Marketing Authorization Holder (MAH)
  3. CTD/ACTD dossier preparation and submission
  4. Technical evaluation by DAV (quality, safety, efficacy)
  5. Issuance of Marketing Authorization
  6. Post-approval Regulatory maintenance, including renewals and variations

Marketing Authorizations are generally valid for five (5) years, with defined procedures for renewals, line extensions, and post-approval changes.

Pharmacovigilance and Post-Approval Compliance

DAV requires MAHs to maintain a robust pharmacovigilance system in Vietnam. This includes:

  • Appointment of a local pharmacovigilance responsible person
  • Submission of ADR and serious adverse event reports
  • Periodic safety updates, as applicable
  • Ongoing compliance with labeling and risk-minimization measures

Post-approval compliance is a critical component of pharmaceutical Regulatory affairs in Vietnam, with increased inspections and enforcement in recent years.

Coordination with Other Health Authorities

While DAV regulates drugs and medicinal products, other MOH departments support related areas:

  • Department of Medical Equipment and Construction (DMEC) – Medical devices and diagnostics
  • Provincial Departments of Health – Local enforcement and inspections

This coordinated framework ensures comprehensive Regulatory oversight across the pharmaceutical value chain.

Why the Drug Administration of Vietnam Matters for Global Pharma Companies

Vietnam is one of Southeast Asia’s fast-growing pharmaceutical markets, making Regulatory compliance and strategic planning essential for:

  • New drug registrations
  • Generic and biosimilar approvals
  • Lifecycle management and variations
  • ASEAN regional expansion strategies

A clear understanding of DAV’s Regulatory expectations enables companies to reduce approval timelines, avoid deficiencies, and maintain compliance.

Conclusion

The Drug Administration of Vietnam (DAV) is the authoritative body regulating medicinal products and pharmaceuticals in Vietnam, operating under the Ministry of Health. Through its oversight of drug registration, GMP compliance, pharmacovigilance, and post-approval obligations, DAV plays a central role in ensuring safe, effective, and high-quality medicines reach the Vietnamese market.

Need Support with Drug Registration or Regulatory Affairs in Vietnam?

Freyr Solutions provides end-to-end Vietnam pharmaceutical Regulatory services, including Regulatory strategy, CTD dossier preparation, DAV submissions, local representation support, and lifecycle management.

Connect with our Vietnam Regulatory Affairs Experts to accelerate your market entry.