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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

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Showing 61 - 70 of 150
8 October 2020

If sponsorship is transferred to you, you need to notify the TGA

Tags: 
ARTG
27 April 2015

Information on use of the TGA business services website

3 October 2018

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

Use this form to apply for an additional trade name for a registered prescription medicine

Tags: 
forms
20 November 2020

XML schema and related files to assist with compiling a NeeS or eCTD dossier

Tags: 
CTD, eCTD
10 July 2019

Changing the PI of a generic medicine so that the indications match the reference medicine

Tags: 
generic medicines, product information
27 July 2018

Guidance on the format requirements for dossiers

Tags: 
CTD

Use these forms to request a meeting and to record agenda items and outcomes

Tags: 
forms
15 December 2019

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

Tags: 
manufacturing, GMP
12 January 2017

Information about PPF-only pre-submission phase of priority registration

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