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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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23 March 2018

Guidance on completing a determination or designation application form in TGA Business Services

Tags: 
fast track approvals, orphan drugs