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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 November 2020
November
20
2020

XML schema and related files to assist with compiling a NeeS or eCTD dossier

November
10
2020

Notices about electronic submissions and data review

November
06
2020

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93

Showing 1 - 3 of 3
18 January 2018

Information on national policy for applying access restrictions on all "poisons", which includes medicines for human therapeutic use (as defined in the Poisons Standard)

Tags: 
poisons standard, scheduling
30 July 2019

Guidance on how the Poisons Standard is amended and the processes that underpin scheduling policy

Tags: 
poisons standard, scheduling
18 January 2019

Labelling requirements in some appendices to the Poisons Standard

Tags: 
poisons standard, medicine labels