Overview and Background
ACTD stands for “ASEAN Common Technical Dossier,” and refers to the common technical dossier for marketing authorization applications in the Association of Southeast Asian Nations (ASEAN).
In other words, it is the common dossier format used when submitting applications for manufacturing and marketing approval of human medicinal products in ASEAN member states.
In Europe and the United States, there is the ICH-defined Common Technical Document (CTD). The ACTD follows that model and is a format adjusted for the ASEAN region.
ASEAN has pursued regional integration of medicines regulation, and as part of that effort, ACTD was introduced by each country starting in January 2009.
At the same time, guidelines on long-term stability testing, process validation, and bioavailability/bioequivalence (BA/BE) studies were harmonized. Since then, in ASEAN member states (e.g., Indonesia, Malaysia, Singapore, Thailand, Viet Nam), ACTD-format submissions have been required for new drug applications.
The aim was to unify previously divergent national submission requirements to achieve more efficient reviews and reduced burden on applicants.
In addition, paving the way toward future electronic submissions (eCTD) was also one of the objectives.
Main Requirements and Standards
The ACTD is a guideline that defines the structure of the application dossier and consists of four parts (Part I–IV).
The contents of each part are as follows.
Part I: Administrative and Product Information
This corresponds to the main body of the application.
It comprises the application form, applicant information, product overview (product name, dosage form, strength, etc.), labeling/package inserts (including instructions and precautions), list of manufacturers, various declarations and letters of authorization required for approval, and other documents required by each national authority.
Because these must be submitted in accordance with each country’s laws and regulations, the ACTD provides example formats only; details may vary by country.
Part II: Quality (Chemical, Pharmaceutical)
Data related to the quality of the active substance and finished product.
Specifically, it covers the active substance name, structural formula, manufacturing process, impurity profile; formulation composition; manufacturing method; specifications and test results (quality tests); stability data; and other CMC (Chemistry, Manufacturing, and Controls) information.
Part II is required for both new drugs and generics, and its structure is tightly defined (four sections: Overview, List of documents, Detailed data, and References).
Part III: Nonclinical (Safety)
Data from nonclinical studies conducted in animals and in vitro.
It includes basic pharmacology (pharmacodynamics), pharmacokinetics (ADME), and toxicology (single-dose, repeat-dose, genotoxicity, reproductive/developmental toxicity, carcinogenicity, etc.).
This corresponds to Module 4 of the ICH-CTD and is an important part that provides the scientific basis supporting a medicine’s efficacy and safety.
Part IV: Clinical (Efficacy)
Data from clinical studies conducted in humans.
It includes clinical pharmacology studies (early PK/PD), Phase I–III clinical trial results and integrated reports, literature data, and post-marketing information (where approved/marketed overseas).
This corresponds to Module 5 of the ICH-CTD and compiles the clinical data demonstrating the efficacy and safety of the product under application. It typically constitutes a large body of materials such as patient listings for each trial and statistical analyses.
The above is the basic ACTD structure; each part is further subdivided, and applicants prepare documents accordingly.
ACTD is, fundamentally, a guideline that standardizes the table of contents for submitted materials, while separate ICH guidelines and national regulations specify “what content should be provided under each heading.”
For example, stability requirements are set out in the ASEAN Stability Guidelines, and clinical requirements follow ICH E-series (Efficacy) guidelines. In this way, ACTD provides a **format for organizing and presenting application dossiers**, and is distinct from the actual evaluation standards for the product.
Applicants must map their information into the ACTD framework and ensure that complete data are provided.
Significance and Benefits of Adoption
The primary significance of adopting ACTD is the streamlining and facilitation of marketing authorization reviews.
Previously, each ASEAN country had its own application format and required data items. Thus, applying for approval of the same product in multiple ASEAN countries meant recreating dossiers for each country, imposing a substantial burden on applicants.
With ACTD, preparing the dossier according to a single common format allows acceptance across ASEAN countries, simplifying preparations for manufacturers. This accelerates new product launches and, ultimately, enables patients in the ASEAN region to access new treatments sooner.
For regulators, unified dossier structures make reviews easier and can shorten review timelines. In practice, common formatting has reduced deficiency letters, and some countries have reported shorter review periods than before.
Another benefit of ACTD is regulatory harmonization and strengthened cooperation within the region. During ACTD development, representatives from ASEAN member authorities met repeatedly to draft the guidelines.
Through this joint work, information sharing and trust were strengthened, fostering coordination beyond approvals (e.g., GMP inspections and post-marketing safety). Looking ahead, ASEAN envisions quasi-mutual recognition mechanisms and even region-wide authorization systems.
As a foundation, standardizing documentation via ACTD has played a major role. Moreover, as companies compile ACTD-conforming dossiers, their ability to organize and analyze data improves, enabling more transparent and consistent submissions.
This, in turn, enhances applicants’ development and submission capabilities and ultimately promotes the development of high-quality medicines.
That said, ACTD is a guideline and does not itself carry legal force. Some country-specific additional requirements remain, so full unification still faces challenges.
Nevertheless, the shared commitment by authorities and industry to use a common format is meaningful in itself and serves as a foundation for ASEAN regulatory harmonization. For companies, once a dossier is prepared in ACTD format, it can often be adapted with minor adjustments for multiple countries—yielding clear benefits in reduced approval costs and higher success rates.
Overall, the introduction of ACTD was an important step that improved access to medicines in ASEAN and strengthened the international competitiveness of the industry.
Impact on Products, Services, and Consumers
While ACTD’s benefits primarily concern processes involving manufacturers and regulators, the ultimate stakeholders are patients and consumers. By making review and approval more efficient, ACTD shortens the time for new and generic medicines to reach markets across ASEAN.
For instance, when an innovative medicine was developed, differing national formats once led to approval lags of years in some countries. After ACTD, faster dossier preparation narrowed approval timing gaps among countries.
As a result, patients across ASEAN can access new medicines earlier, helping to reduce regional disparities in treatment opportunities.
In addition, clearer and more complete dossier content under ACTD can indirectly improve medicine quality and safety. As companies reorganize their data under a common format, inconsistencies and gaps may be identified and corrected.
Consequently, the reliability of submissions increases and reviews proceed appropriately. Medicines that reach the market have been more thoroughly assessed, providing greater assurance for consumers.
Over the longer term, ACTD is also expected to catalyze adoption of electronic submissions (eCTD) across ASEAN. With e-submissions, risks such as mailing errors and document loss decline, and interactions between authorities and applicants become smoother.
This leads to faster feedback on review outcomes (approval decisions) and helps ensure timely supply to the market—ultimately supporting an environment where patients can obtain needed medicines when they need them.
In short, although ACTD is not directly visible to consumers, its effects are steadily realized as improved access to new medicines and greater confidence in pharmaceuticals, benefiting consumers.
Relevant International Bodies and Regulators
ACTD was developed within the ASEAN framework. The lead forum was the ASEAN Pharmaceutical Product Working Group on regulatory harmonization, with participation from authorities of member countries (Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Viet Nam, Lao PDR, Myanmar, and Cambodia).
The ACTD guideline itself has been adopted as an official ASEAN document by national health authorities and is now implemented as part of national regulatory systems. For example, Malaysia’s NPRA, Thailand’s FDA, and Indonesia’s BPOM have issued domestic directives requiring ACTD-conforming submissions.
Internationally, ACTD aligns closely with the ICH CTD (the global Common Technical Document). While ICH is a forum among Japan, the U.S., and the EU, the CTD it developed is used worldwide.
ACTD is based on CTD while incorporating ASEAN-specific circumstances. Therefore, it has much in common with ICH, EU, and U.S. FDA expectations and can be readily leveraged when preparing submissions outside ASEAN.
In fact, some ASEAN member states are considering future participation in ICH, and ACTD implementation experience serves as groundwork.
Related to ACTD, ASEAN has also issued ACTR (ASEAN Common Technical Requirements), a series of technical requirement guidelines. ACTR documents—modeled on ICH—specify detailed content and standards for each part.
Examples include the Stability ACTR and BA/BE ACTR. These can be viewed as “ASEAN versions” of ICH guidelines and form another pillar of ASEAN regulatory harmonization.
Authorities review applications with ACTD and ACTR together, striving to reduce divergence among member states.
In sum, although ACTD is a regional initiative within ASEAN, it draws on the expertise of international bodies such as ICH and WHO and fosters information exchange among regulators inside and outside the region.
Regulation of medicines requires global collaboration, and the ASEAN ACTD is a successful region-led example contributing to that effort.