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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
July
20
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)

July
07
2021

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

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Showing 21 - 30 of 148
23 December 2020

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

Tags: 
CTD, eCTD, electronic submissions
3 June 2013

Information tables describing which modules are required in CTD module 1 for different application types

Tags: 
CTD
3 June 2013

Information tables describing which modules are required in CTD modules 2 to 5 for different application types

Tags: 
CTD
26 May 2014

Information on registration of fixed combination prescription medicines

12 July 2013

Fees payable and timeframes for different types of prescription medicine applications

Tags: 
fees/payments
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

Tags: 
chemicals, variations
31 July 2013

Guidance on when and how to provide PI to the TGA

Tags: 
product information
16 October 2019

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

Tags: 
blood, variations, eCTD, electronic submissions, DMF

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