##  [What Is ACTD? Understanding the ASEAN Common Technical Dossier](/index%2ephp/what-is-actd-understanding-the-asean-common-technical-dossier) 

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The **ASEAN Common Technical Dossier (ACTD)** is a harmonized regulatory dossier format developed to streamline **drug registration across ASEAN member countries**, including Thailand, Malaysia, Indonesia, Vietnam, the Philippines, and others. Introduced under the ASEAN Consultative Committee for Standards and Quality – Pharmaceutical Product Working Group (ACCSQ-PPWG), ACTD aims to reduce duplication, improve submission efficiency, and promote regulatory convergence across the region.

## Purpose of ACTD

ACTD provides a **standardized structure for pharmaceutical submissions**, allowing sponsors to use a common dossier format while addressing country-specific administrative requirements. By aligning technical data presentation, ACTD helps regulators assess quality, safety, and efficacy more consistently across ASEAN markets.

### ACTD Structure

Unlike the ICH Common Technical Document (CTD), ACTD follows a **four-part structure**:

- **Part I: Administrative Data and Product Information**  
    Includes application forms, labeling, and regional administrative documents.
- **Part II: Quality**  
    Covers drug substance and drug product information, manufacturing processes, specifications, and stability data.
- **Part III: Nonclinical**  
    Contains pharmacology and toxicology data demonstrating product safety.
- **Part IV: Clinical**  
    Includes clinical study reports or bioequivalence data, depending on the product type.

ACTD is commonly used for **generic drugs, line extensions, and certain new products**, while some ASEAN authorities may still require CTD format for New Chemical Entities (NCEs).

### Why ACTD Matters

ACTD simplifies multi-country submissions, reduces regulatory complexity, and supports **faster market access** across ASEAN. However, despite harmonization, each country applies **local variations, review timelines, and data expectations**, making regional expertise essential.

### How Freyr Solutions Can Help

At **Freyr Solutions**, we provide **end-to-end ACTD support**—from strategy and dossier preparation to country-specific customization and authority interactions across ASEAN markets.

**Looking to accelerate your ASEAN submissions?**

Partner with Freyr Solutions to navigate ACTD requirements with confidence and bring your products to market faster.