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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.