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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 - 11 October 2021
September
25
2021

Information regarding the export of therapeutic medicines, medical devices and human substances

September
24
2021

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

Showing 1 - 7 of 7
23 October 2019

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods Order 100

Tags: 
regulatory guidance
29 March 2021

Links to information on TGA approved terminology for medicines

Tags: 
regulatory guidance
30 March 2020

Approved terminology on the TBS website - ingredients table and code tables

Tags: 
regulatory guidance
30 March 2020

Guidance on proposing a new ingredient name to be included on the approved list

Tags: 
regulatory guidance
30 March 2020

Requirements of approved names for medicine ingredients

Tags: 
regulatory guidance
30 March 2020

Approved terminology on the TBS website - code tables

Tags: 
regulatory guidance
22 September 2020
Guidance on how to request Early Scientific Advice on a biowaiver justification.
Tags: 
forms, generic medicines, regulatory guidance