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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 1 - 10 of 20

Use this form to prepare certified product details (CPD) for biological prescription medicines

Tags: 
variations, biological medicines, forms
22 December 2020

Information on the TGA Laboratories testing program for therapeutic goods

Tags: 
testing
2 January 2019

Information about shortages of reportable medicines in Australia

Tags: 
medicine shortages
6 March 2017

Guidance for sponsors on demonstrating stability of medicines under Australian conditions

Tags: 
testing
29 March 2019

Guidance on risk management plan (RMP) requirements

Tags: 
risk management, pharmacovigilance
24 August 2021

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

Tags: 
pharmacovigilance, reporting problems, risk management
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
14 January 2020

Guidance on procedure to undertake recalls and non-recall actions on therapeutic goods

Tags: 
recalls
19 January 2021

Guidance on pharmacovigilance responsibilities, mandatory reporting requirements and pharmacovigilance best practice

Tags: 
pharmacovigilance

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