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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

Information about pre-submission meetings and when to request one

Showing 1 - 6 of 6
23 March 2018

Guidance on completing a determination or designation application form in TGA Business Services

Tags: 
fast track approvals, orphan drugs
20 March 2018

Information on the provisional approval pathway for prescription medicines

Tags: 
fast track approvals
24 October 2018

Guidance on applying for a provisional determination, which is the first step of the provisional approval pathway

Tags: 
fast track approvals
20 March 2018

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

Tags: 
fast track approvals
2 August 2018

Guidance on provisional registration process for prescription medicines with provisional determination

Tags: 
fast track approvals
2 September 2019

Guidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration

Tags: 
fast track approvals