A registration dossier has to answer the same set of questions wherever it is filed: what is the product, how is it made, how is it controlled, and what is known about its use. The CTD and the ACTD organise those answers differently, because they were written for different regions.
What the CTD organises
The ICH Common Technical Dossier arranges information into five modules. Module 1 covers region-specific administrative material. Module 2 holds summaries and the overall quality overview. Module 3 covers quality — the chemistry, manufacturing and controls section, which is usually the largest part of the submission. Module 4 addresses non-clinical studies and Module 5 clinical studies. Many markets require Modules 3 and 4 only, with clinical data not required for an established generic.
What the ACTD organises
The ASEAN Common Technical Dossier arranges the same underlying material into four Parts rather than five modules. Part I contains administrative information and the summaries. Part II corresponds closely to quality. Part III addresses non-clinical information and Part IV clinical information. Some ASEAN national authorities add local requirements that sit outside this structure.
Why the distinction is not academic
Your authority will expect one structure or the other. A dossier submitted in the wrong format is usually returned for resubmission, which delays the application by however long the submission cycle takes — commonly several months. This is avoidable, and it is worth confirming the required format before any substantial work begins.
Spanish-language requirements
Several Latin American authorities require submission documents in Spanish rather than English. This affects not only the dossier but supporting material such as certificates and labelling. Confirm with the authority whether sworn translation is required for any part of the submission.
A practical approach
Ask your supplier which dossier format they hold for your specific market, in which language, and how recently it was compiled. A current dossier reduces your application to a review exercise rather than a drafting exercise. Where no dossier exists for your market, establish early whether translation and local formatting can begin before your own registration work starts.
This article describes general structure only and is not regulatory or legal advice. The required format and language must be confirmed with the competent authority of the importing country, and requirements change over time.
A Chinese GMP certificate confirms compliance with Chinese regulatory requirements. It is not a foreign approval, and it is not a substitute for your own authority's assessment.
Descriptions, limits and test methods — what each part tells you and what it does not.