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Australian Regulatory Guidelines for Prescription Medicines (ARGPM) BETA

The ARGPM is a collection of guidance documents and other information about the regulation of prescription medicines. The ARGPM has been designed for use by sponsors to provide a way to search for relevant TGA guidance documents about prescription medicines from a single location. Commonly used ARGPM documents, including basic information, CTD and general dossier requirements and forms, can be found at medicine registration fundamentals.

This is a beta version of the new ARGPM and we welcome your feedback while the new tool is being tested. The previous version of the ARGPM will remain available for a short time.

To use the ARGPM, filter the list of documents by selecting topics, sub-topics or tags, or search using keywords. The search or filtered results are limited to relevant items within the ARGPM. If you cannot find the document you are looking for you can search the entire website using the main site search.

Latest updates - 11 October 2021

Information regarding the export of therapeutic medicines, medical devices and human substances


This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

Showing 1 - 3 of 3
29 March 2019

Guidance on risk management plan (RMP) requirements

risk management, pharmacovigilance
19 January 2021

Guidance on pharmacovigilance responsibilities, mandatory reporting requirements and pharmacovigilance best practice

18 October 2019

How to use E2B R2 format to provide information about adverse events

pharmacovigilance, reporting problems