Guidance documents for therapeutic products

Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products.

Product registration and post approval variation

Main guidance


Retention on Therapeutic Product Register

Change of registrant

ASEAN Common Technical Dossier (ACTD)

ASEAN Registration of Pharmaceuticals for Human Use

ASEAN Common Technical Requirements (ACTR)

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for Therapeutic Products

Reporting of Therapeutic Product Defects and Recall of Therapeutic Products

Clinical trials of therapeutic products

Refer to our clinical trials section for the guidance documents.