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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 121 - 130 of 150
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
7 May 2018

Guidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members

Tags: 
ACM
8 May 2018

Guidance on meeting the requirements for child-resistant packaging in TGO 95

Tags: 
children/child
28 October 2020

Your responsibilities when advertising therapeutic guides

10 November 2020

Notices about electronic submissions and data review

Tags: 
CTD, eCTD
15 August 2018

Evaluation plan estimators to approximate dates of milestones in the prescription medicine registration process

18 October 2019

How to use E2B R2 format to provide information about adverse events

Tags: 
pharmacovigilance, reporting problems
29 September 2020

Provides links to guidance and resources about medicine shortages in Australia for sponsors

Tags: 
medicine shortages
1 May 2019

Information about management and communication of medicine shortages and discontinuations in Australia

Tags: 
medicine shortages
29 November 2018

Guidance on how and when to use a Boxed Warning

Tags: 
product information, CMI, side effects

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