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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 November 2021
November
16
2021

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93

November
10
2021
Information about the role & members of the Advisory Committee on Medicines (ACM)
Showing 1 - 3 of 3
29 November 2018

Guidance on how and when to use a Boxed Warning

Tags: 
product information, CMI, side effects
27 April 2015

How to upload your PI in TGA Business Services

Tags: 
product information, CMI

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

Tags: 
product information, CMI