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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 - 22 June 2021
June
22
2021

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

June
21
2021

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

June
16
2021
Guidance on how to submit shortage/discontinuation notifications to the TGA
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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

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
27 October 2020

This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA

Tags: 
variations, forms, drug master files, DMF, ASMF, Master file