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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

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Showing 71 - 80 of 150
19 July 2019

Guidance on processes used to test biological medicines during and after registration

Tags: 
biological medicines, testing
22 December 2015

Guidance on temperature excursions of biological medicines

Tags: 
biological medicines, testing

Use this form to apply for consent to import, supply or export therapeutic goods that do not comply with standards

Tags: 
forms
13 October 2020

Information on requirements and process to apply to import, supply or export therapeutic goods that do not comply with standards

30 March 2020

Approved terminology on the TBS website - ingredients table and code tables

Tags: 
regulatory guidance
30 March 2020

Information about the legal basis for using approved terminology for medicines

30 March 2020

Guidance on proposing a new ingredient name to be included on the approved list

Tags: 
regulatory guidance
30 March 2020

Requirements of approved names for medicine ingredients

Tags: 
regulatory guidance
30 March 2020

Information about using approved names for chemical ingredients in medicines

Tags: 
chemicals
30 March 2020

Information about using approved names for biological ingredients in medicines

Tags: 
biologicals

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