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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 - 11 October 2021
September
25
2021

Information regarding the export of therapeutic medicines, medical devices and human substances

September
24
2021

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

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Showing 51 - 60 of 147
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

29 March 2021

Links to information on TGA approved terminology for medicines

Tags: 
regulatory guidance
24 August 2021

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
7 July 2021

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

Tags: 
AusPARs
8 October 2020

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

Tags: 
ARTG

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