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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).

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Use this form to submit a summary of a bioavailability or bioequivalence study

forms, generic medicines

Use this declaration for products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell

stem cells, forms
26 May 2014

Information on registration of fixed combination prescription medicines

5 April 2019

Requirements to demonstrate safety with regard to adventitious agents and how to register or list a medicine that contains or are manufactured using materials of animal or human origin

eCTD, Master file
6 March 2017

Guidance for sponsors on demonstrating stability of medicines under Australian conditions

23 October 2019

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods Order 100

regulatory guidance
9 August 2013

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG)

4 October 2019

Data requirements for formulation changes to inhalation and nasal spray medicines

generic medicines, variations
12 July 2013

Guidance on radiopharmaceutical entry in the ARTG

12 July 2013

Information on prescription medicines that contain, or are produced by, genetically modified organisms (GMOs)