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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 November 2020
November
20
2020

XML schema and related files to assist with compiling a NeeS or eCTD dossier

November
10
2020

Notices about electronic submissions and data review

November
06
2020

Information about pre-submission meetings and when to request one

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Showing 41 - 50 of 150
21 February 2018

Guidance on information that must be submitted for an effective application to proceed to evaluation

Tags: 
CTD
26 May 2014

Information on special considerations required for medicines for use in special populations

4 April 2018

How to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities

29 March 2019

Guidance on risk management plan (RMP) requirements

Tags: 
risk management, pharmacovigilance
27 May 2014

Guidance on required format for literature based submissions

27 May 2014

Guidance about using literature based submissions

27 May 2014

Information on requirements of a systematic literature search

A list of forms for the prescription medicines industry to use when communicating with TGA

Tags: 
CTD, forms
16 October 2019

Information and notices about AusPARs

Tags: 
AusPARs
28 November 2016

Information on AusPARs

Tags: 
AusPARs

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