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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 - 20 July 2021

Use this form to provide formulation details and information on a proprietary ingredient for entry into the Proprietary Ingredient Table in TGA Business Services (TBS)


Guidance on the structure and processes for the compilation, review and publishing of an AusPAR



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Search database of European Union (EU) and International Conference on Harmonisation (ICH) Guidelines adopted in Australia

Code tables in TGA Business services

8 April 2020
Information regarding the export of therapeutic medicines, medical devices and human substances
controlled substances, exporting
Information regarding the import of therapeutic goods, unapproved therapeutic goods and importing controlled substances
controlled substances, exporting
29 March 2021

Information about using approved names for biological ingredients in medicines

7 February 2020
Guidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100
medicinal cannabis
22 September 2020
Guidance on how to request Early Scientific Advice on a biowaiver justification.
forms, generic medicines, regulatory guidance
8 October 2020
Guidance on how to change sponsor details in PI and labels
product information, medicine labels, variations