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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 - 4 of 4
15 December 2019

Guidance on preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines

Tags: 
manufacturing, GMP
10 July 2019

Links to information on variations to prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines, manufacturing
4 August 2017

This guidance applies when GMP clearance is obtained by any pathway, or by GMP certification following a TGA inspection

Tags: 
manufacturing
26 June 2019

Guidance on obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site

Tags: 
manufacturing