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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 April 2021
April
23
2021

Guidance on eligibility criteria and supporting documentation when preparing an application for orphan drug designation

April
23
2021

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

Showing 1 - 6 of 6
3 August 2020

Guidance on the process and relevant regulatory requirements to register prescription medicines

21 February 2018

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

Tags: 
CTD
29 March 2019

Guidance on risk management plan (RMP) requirements

Tags: 
risk management, pharmacovigilance
15 December 2019

Guidance on preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines

Tags: 
manufacturing, GMP
8 April 2020
Information regarding the export of therapeutic medicines, medical devices and human substances
Tags: 
controlled substances, exporting
Information regarding the import of therapeutic goods, unapproved therapeutic goods and importing controlled substances
Tags: 
controlled substances, exporting