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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

Filters
Showing 1 - 10 of 37

Use this form to prepare certified product details (CPD) for biological prescription medicines

Tags: 
variations, biological medicines, forms

Use this form to prepare certified product details (CPD) for chemical prescription medicines

Tags: 
variations, forms

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

Links to information about TGA Business Services (TBS)

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
11 August 2017

Guidance on prescription medicine clinical evaluation streams and the functions each unit provides

6 November 2020

Information about pre-submission meetings and when to request one

12 July 2013

Guidance on submitting the Certified Product Details (CPD) for prescription medicines

Tags: 
chemicals, variations
16 October 2019

Guidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma

Tags: 
blood, variations, eCTD, electronic submissions, DMF

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