You are here

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).

Filters
Showing 1 - 10 of 34

Use this form to begin the first phase of the prescription medicine registration process

Tags: 
forms

Application form to register or vary the registration of prescription medicines and checklist to determine if the application is eligible for COR-A or COR-B report-based approach

Tags: 
variations, forms

Links to information about fees and payments

Tags: 
fees/payments
16 September 2021

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

Tags: 
international
12 July 2013

Fees payable and timeframes for different types of prescription medicine applications

Tags: 
fees/payments
12 August 2021

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

29 March 2019

Guidance on risk management plan (RMP) requirements

Tags: 
risk management, pharmacovigilance
27 May 2014

Guidance on required format for literature based submissions

27 May 2014

Guidance about using literature based submissions

27 May 2014

Information on requirements of a systematic literature search

Pages