Get The Asean Common Technical Dossier Actd For The

This guide provides a comprehensive and user-friendly overview of how to effectively fill out the ASEAN Common Technical Dossier (ACTD) for the registration of pharmaceuticals for human use, specifically focusing on the nonclinical document. Follow these steps to ensure accurate and complete submission.

Follow the steps to accurately complete the online form.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin by filling out the Table of Contents in Section A. List all sections and subsections accurately to provide a clear roadmap of your submission.
3. In Section B, the Nonclinical Overview, present an integrated summary of pharmacologic and toxicologic evaluations. Ensure that the good laboratory practice status of your studies is discussed.
4. Proceed to Section C to provide detailed nonclinical written summaries. Organize content logically, starting with pharmacology, followed by pharmacokinetics, and then toxicology.
5. In Section D, compile all Nonclinical Study Reports. List study types and corresponding details such as methodology, dosing, and study outcomes for each category of reports.
6. Finally, in Section E, include a list of key literature references in accordance with the 1979 Vancouver Declaration or relevant citation systems. Ensure to attach copies of critical references.
7. Once all sections are completed, review your entries for clarity and correctness. You can then save changes, download, print, or share the form for submission.

Start completing your ACTD form online to ensure your application is processed smoothly.