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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 December 2020
December
23
2020

Guidance on the information required in CTD module 1 - for applications received by TGA after February 2018

December
22
2020

Information on the TGA Laboratories testing program for therapeutic goods

December
15
2020

The prescription medicine notification process

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Showing 111 - 120 of 150
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
24 May 2018

Text to include in PI for products in the Black Triangle Scheme

Tags: 
reporting problems, side effects
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
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

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