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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 - 23 December 2020
December
23
2020

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

December
22
2020

Information on the TGA Laboratories testing program for therapeutic goods

December
15
2020

The prescription medicine notification process

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Showing 101 - 110 of 150
26 June 2019

Guidance on obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site

Tags: 
manufacturing
27 June 2018

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

Tags: 
pharmacovigilance
30 August 2017

Information to support submission of quality modules as part of registration or variation applications for influenza vaccines

Tags: 
vaccines
18 October 2017

Specifications and guidance to compile an eCTD dossier for Australia

Tags: 
CTD, eCTD
20 May 2020

Options for alternative medicines, including medicines approved for import and supply during a shortage (s. 19A approvals)

Tags: 
medicine shortages
4 January 2018

Information for industry about supplying substitute medicines during a medicines shortage

Tags: 
medicine shortages
10 July 2019

E-form specific information

Tags: 
variations
18 October 2017

Specifications and guidance to compile a NeeS dossier in Australia

Tags: 
CTD
24 October 2019

Information about how TGA makes use of assessments from comparable overseas regulators (CORs)

Tags: 
international
24 October 2019

List of countries and jurisdictions TGA will accept reports from for use in the COR report-based process

Tags: 
international

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