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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 November 2020
November
20
2020

XML schema and related files to assist with compiling a NeeS or eCTD dossier

November
10
2020

Notices about electronic submissions and data review

November
06
2020

Information about pre-submission meetings and when to request one

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Showing 11 - 20 of 150

Use this form to notify TGA of a proposal to submit supplementary data and to submit supplementary data

Tags: 
forms

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)

Tags: 
forms
5 June 2017

Information on the TGA Laboratories testing program for therapeutic goods

Tags: 
testing

Links to information about fees and payments

Tags: 
fees/payments

Links to information about TGA Business Services (TBS)

15 October 2020

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

Tags: 
international
2 January 2019

Information about shortages of reportable medicines in Australia

Tags: 
medicine shortages
6 March 2020

Information to assist sponsors with reformatting their approved PI or preparing a new PI in the required format

Tags: 
product information, variations

Links to information about labelling and packaging

Tags: 
medicine labels
7 May 2020
Frequently asked questions (FAQs) about exporting medicines, medical devices and human substances and export certificates including the Certificate of Pharmaceutical Product (CPP), Certificate of Listed Product (CLP) and Certificate of Free Sale (CFS)
Tags: 
questions & answers, exporting

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