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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 51 - 60 of 150
7 May 2014

Information on how official information of a business or commercial nature, provided to the TGA, is treated

20 January 2017

How to request reconsideration of 'reviewable' initial decisions by the Minister for Health

Tags: 
regulatory actions/decisions
18 May 2017

A code of practice for those involved in the design, selection and use of tamper-evident packaging

Tags: 
tamper-evident packaging
16 June 2014

Overview of the Common Technical document, modules 1-5

Tags: 
CTD, eCTD
27 May 2014

Information on how to compile a literature based submission (including mixed applications)

28 August 2018

Guidance on colourings in medicines for topical and oral use

30 March 2020

Links to information on TGA approved terminology for medicines

Tags: 
regulatory guidance
18 September 2019

How to design and conduct post-marketing surveillance (PMS) studies

Tags: 
pharmacovigilance, reporting problems, risk management
27 October 2020

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA

Tags: 
variations, forms, drug master files, DMF, ASMF, Master file
11 March 2015

Guidance on the structure and processes for the compilation, review and publishing of an AusPAR

Tags: 
AusPARs

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