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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 - 20 July 2021
July
20
2021

Use this form to provide formulation details and information on a proprietary ingredient for entry into the Proprietary Ingredient Table in TGA Business Services (TBS)

July
07
2021

Guidance on the structure and processes for the compilation, review and publishing of an AusPAR

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
22 June 2021

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

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international
12 July 2013

Fees payable and timeframes for different types of prescription medicine applications

Tags: 
fees/payments
3 August 2020

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

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