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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

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Showing 11 - 20 of 148

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

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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)

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forms
22 December 2020

Information on the TGA Laboratories testing program for therapeutic goods

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testing

Links to information about fees and payments

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fees/payments

Links to information about TGA Business Services (TBS)

22 June 2021

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

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international
2 January 2019

Information about shortages of reportable medicines in Australia

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medicine shortages
6 March 2020

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

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product information, variations

Links to information about labelling and packaging

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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)
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questions & answers, exporting

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