##  [What Is Vietnam’s New 2026 Regulatory Framework and How Will It Affect Drug Registration?](/index%2ephp/what-is-vietnams-new-2026-regulatory-framework-and-how-will-it-affect-drug-registration) 

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## 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?**

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