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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

Showing 1 - 9 of 9
2 January 2019

Information about shortages of reportable medicines in Australia

Tags: 
medicine shortages
ACM meeting statements which describe matters considered by ACM at each meeting
Tags: 
ACM, committee statements
15 August 2018

Evaluation plan estimators to approximate dates of milestones in the prescription medicine registration process

Search for newly added or updated PI documents using TGA Business Services

Tags: 
product information

Search for a PI by medicine or trade name or active ingredient using TGA Business Services

Tags: 
product information, CMI
14 July 2020

Search database of TGA Laboratory testing results

Tags: 
testing

Search database of AusPARs

Tags: 
AusPARs

Search database of European Union (EU) and International Conference on Harmonisation (ICH) Guidelines adopted in Australia

Code tables in TGA Business services