2 min read

Introduction

As Vietnam enters 2026, the country's pharmaceutical Regulatory landscape is undergoing one of its most significant transformations in years. With accelerated alignment toward ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR), global and regional manufacturers must prepare for a more harmonized, transparent, and quality-driven Regulatory environment.

This shift is part of Vietnam’s broader strategy to improve therapeutic access, streamline review timelines, and strengthen its Regulatory system in line with international standards.

1. ASEAN ACTD/ACTR Becomes Central to Vietnam’s Regulatory Framework in 2026

By early 2026, Vietnam’s Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) are expected to fully implement ACTD/ACTR requirements across all new drug applications, focusing on:

  • Standardized dossier structure
  • Better alignment with ICH-quality principles
  • Reduced duplication of data
  • Harmonized requirements with other ASEAN member states

This transition makes regional submissions more predictable and allows global companies to leverage existing ASEAN dossiers with minimal adaptation.

2. Impact on CTD-Based Submissions

While Vietnam previously accepted both CTD and ACTD formats, the trend in 2026 strongly favors ACTD as the primary submission format for:

  • New Drug Applications (NDA)
  • Generic drug applications
  • Variations and renewals
  • Imported and locally manufactured products

Manufacturers must now ensure that all modules—especially M3 (Quality) and M4 (Clinical)—are adapted precisely to ACTD structure.

3. Strengthened GMP Requirements for Imported Drugs

A major 2026 update is Vietnam’s increased emphasis on GMP equivalence for foreign manufacturers. Imported products may require:

  • Stronger PIC/S GMP evidence
  • Inspection readiness for potential on-site audits
  • Robust stability, validation, and product quality data

Regulators have signaled a prioritization of risk-based GMP inspections, especially for medicinal products in oncology, injectables, biologics, and high-risk categories.

4. Expected Benefits for Manufacturers

The full adoption of ACTD/ACTR simplifies regional operations, offering:

  • Shorter Regulatory timelines for well-prepared dossiers
  • Higher predictability in MOH reviews
  • Reduced dossier customization across ASEAN markets
  • Stronger acceptance of ASEAN reference approvals

For multinational companies, this opens clearer pathways for synchronized submissions across Vietnam, Thailand, Malaysia, Indonesia, and the Philippines.

5. What Manufacturers Should Do in 2026

To stay ahead of Regulatory expectations:

  • Conduct a gap assessment on existing CTD dossiers
  • Adapt to ACTD structure for all new filings
  • Prepare updated GMP evidence aligned with PIC/S
  • Strengthen CMC and stability data packages
  • Monitor new MOH circulars expected in early–mid 2026

Conclusion

Vietnam’s move toward complete ASEAN harmonization marks a pivotal regulatory shift in 2026. Companies that proactively align their dossiers, GMP documentation, and compliance strategies will gain a significant advantage in navigating one of Southeast Asia’s fastest-growing pharma markets.

Ready to launch or expand in Vietnam in 2026?

Let our Vietnam Regulatory experts help with ACTD gap analysis to dossier compilation, GMP readiness assessment, and full MA submission support. Reach out to us to fast-track your Vietnam market entry.