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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 - 16 September 2021
September
16
2021

Information about the Australia-Canada-Singapore-Switzerland (ACSS) Consortium

September
13
2021
Information about the role & members of the Advisory Committee on Medicines (ACM)
August
26
2021

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination

Showing 1 - 2 of 2
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
27 October 2020

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA

Tags: 
variations, forms, drug master files, DMF, ASMF, Master file