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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

Showing 1 - 10 of 17

Forms for notifying the TGA of a change in sponsorship

Tags: 
ARTG, forms
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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

Tags: 
forms, generic medicines

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

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variations, biological medicines, 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

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stem cells, forms

Optional submission dossier checklist

Tags: 
CTD

Use this form to notify TGA of a proposal to submit supplementary data and to submit supplementary data

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forms

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