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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 - 29 March 2021
March
29
2021

Links to information on TGA approved terminology for medicines

March
29
2021

Information about using approved names for biological ingredients in medicines

March
23
2021

Guidance to assist in meeting the Australian labelling requirements in TGO 91 and TGO 92

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Showing 1 - 10 of 149

Forms for notifying the TGA of a change in sponsorship

Tags: 
ARTG, forms
Tags: 
forms, international agreements

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

Tags: 
CTD, forms, eCTD, CEP, GMP

Use this form to begin the first phase of the prescription medicine registration process

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forms

Use this form to submit a summary of a bioavailability or bioequivalence study

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forms, generic medicines

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

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variations, biological medicines, forms

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

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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

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variations, forms

Use this declaration for products that are manufactured using a human embryo or a human embryonic stem cell, or any material sourced from a human embryo or human embryonic stem cell

Tags: 
stem cells, forms

Optional submission dossier checklist

Tags: 
CTD

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