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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 - 23 April 2021
April
23
2021

Guidance on eligibility criteria and supporting documentation when preparing an application for orphan drug designation

April
23
2021

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination

Showing 1 - 6 of 6
22 March 2021

Information about the Australia-Canada-Singapore-Switzerland (ACSS) Consortium

Tags: 
international
24 October 2019

Information about how TGA makes use of assessments from comparable overseas regulators (CORs)

Tags: 
international
24 October 2019

List of countries and jurisdictions TGA will accept reports from for use in the COR report-based process

Tags: 
international
24 October 2019

Guidance on submission requirements for the COR report-based process

Tags: 
international, CORs, Pathways, electronic submissions
24 October 2019

Information about timeframes associated with COR report-based process

Tags: 
international
24 October 2019

Information about requirements for indications of the COR report-based process

Tags: 
international