In my previous blog, we shared briefly on 5 points to look out for when preparing a dossier for submission. In the process of compilation of documents, you often hear your Southeast Asia partners mention about a specific format for submission which is the ASEAN CTD.
So what is ASEAN CTD?
ASEAN CTD stands for ASEAN Common Technical Documentation. It is a collaboration among ASEAN countries to unify common technical requirements and to simplify submission process across ASEAN countries for pharmaceutical products. It is also available as ASEAN CSTD- Medical Devices, ASEAN Product Information File-Cosmetics and so forth. Think of it as a similar approach of having a organized, structured and simplified framework to access to different countries in the region just like how European Union does it. The success of European union is what ASEAN hope to achieve soon down the road.
In European countries, ICH guidelines and format are used for submission of pharmaceutical products to the various health authorities amongst the countries. In ASEAN countries, we follow the ASEAN regulations as well as the ASEAN CTD format for submission. ICH has 5 modules as compared to ASEAN CTD which has 4 parts. The slight difference is in the organization of the documentation into the different parts stated.
ASEAN CTD consists of 4 parts namely : Part I: Administrative Documents, Part II :Quality Documents, Part 3 :Non-Clinical Documents and Part IV :Clinical Documentation. Each part has sub sections divided into Section A, Section B, Section C, Section D and Section E.
In Part I , it consists of the application forms, official letters of authorization, official certificates such as GMP, Manufacturing Licence, Certificate of Pharmaceutical Product (CPP) as well as packaging of the product to be marketed. This is how the section will look like:
Part II focus on the Chemistry Manufacturing Control portion of the active ingredient and the finished product. Information such as Quality Overall Summary(QOS), formulation, manufacturing process, in-process controls, validation, analysis and stability comes in.
Part III will have the non-clinical overview, written summaries and tabulated summaries.Part IV consist of the clinical overview, clinical summary, clinical reports and literature references. Both Part III and Part IV is more applicable for products that have not been registered in any of the member countries before.
Although most ASEAN countries follows the ASEAN CTD Format, however Part 1 requirements will still differ from country to country in terms of such as labelling, application form and official certificates required
Hopefully this simple write up has given you some clarity on ASEAN CTD. Good luck for submission!