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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 July 2021

Use this form to provide formulation details and information on a proprietary ingredient for entry into the Proprietary Ingredient Table in TGA Business Services (TBS)


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




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23 December 2020

Guidance on the information required in CTD module 1 - for applications received by TGA after February 2018

CTD, eCTD, electronic submissions
12 July 2013

Fees payable and timeframes for different types of prescription medicine applications

11 August 2017

Guidance on prescription medicine clinical evaluation streams and the functions each unit provides

2 December 2020

Information about pre-submission meetings and when to request one

12 July 2013

Guidance on submitting the Certified Product Details (CPD) for prescription medicines

chemicals, variations
31 July 2013

Guidance on when and how to provide PI to the TGA

product information
16 October 2019

Guidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma

blood, variations, eCTD, electronic submissions, DMF
5 April 2019

Requirements to demonstrate safety with regard to adventitious agents and how to register or list a medicine that contains or are manufactured using materials of animal or human origin

eCTD, Master file
9 August 2013

Guidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer

6 March 2017

Guidance for sponsors on demonstrating stability of medicines under Australian conditions