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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

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93

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Include these forms, as required, in CTD module 1 to support your application

Tags: 
CTD, forms, eCTD, CEP, GMP

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

Optional submission dossier checklist

Tags: 
CTD
3 August 2020

Guidance on the information required in CTD module 1 - for applications received by TGA after February 2018

Tags: 
CTD, eCTD, electronic submissions
3 June 2013

Information tables describing which modules are required in CTD module 1 for different application types

Tags: 
CTD
3 June 2013

Information tables describing which modules are required in CTD modules 2 to 5 for different application types

Tags: 
CTD
21 February 2018

Guidance on information that must be submitted for an effective application to proceed to evaluation

Tags: 
CTD

A list of forms for the prescription medicines industry to use when communicating with TGA

Tags: 
CTD, forms
16 June 2014

Overview of the Common Technical document, modules 1-5

Tags: 
CTD, eCTD
20 November 2020

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

Tags: 
CTD, eCTD

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