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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

2 September 2019

Ingredients in therapeutic goods

Further information about the types and naming of ingredients and proprietary ingredients in therapeutic goods has recently been published by the TGA

10 July 2019

Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data

The variations guidance provides information about how to make variations to existing ARTG entries for prescription medicines

8 February 2019

Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances

Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allow discretion to reduce application and evaluation fees for a major variation application in exceptional circumstances

29 November 2018

Boxed Warning guidance

The Boxed Warning guidance assists sponsors to understand their obligations and prescribers to understand the rationale for the warning and the magnitude of risk

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Showing 1 - 10 of 143

Links to information about labelling and packaging

Tags: 
medicine labels
28 August 2019

Information and notices about AusPARs

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AusPARs

Links to information about TGA Business Services (TBS)

6 July 2018

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

Tags: 
CTD
26 June 2019

Guidance on obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site

Tags: 
manufacturing
20 March 2018

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

2 January 2019

Information about shortages of reportable medicines in Australia

Tags: 
medicine shortages
16 June 2014

Overview of the Common Technical document, modules 1-5

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CTD

Links to information about fees and payments

Tags: 
fees/payments
10 July 2019

Links to information on variations to prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines, manufacturing

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