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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 - 23 December 2020
December
23
2020

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

December
22
2020

Information on the TGA Laboratories testing program for therapeutic goods

December
15
2020

The prescription medicine notification process

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Showing 91 - 100 of 150
10 July 2019

Types of notifications and variations for biological medicines

Tags: 
variations, biological medicines, generic medicines
8 January 2020

Types of notifications and variations for chemically derived (non-biological) prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines
7 August 2018

Guidance on applying for orphan drug designation of a prescription medicine

Tags: 
orphan drugs

Use this checklist to determine if you have provided all necessary information when applying for Orphan drug designation

Tags: 
forms
7 August 2018

Guidance on eligibility criteria and supporting documentation when preparing an application for orphan drug designation

Tags: 
orphan drugs
23 March 2018

Guidance on completing a determination or designation application form in TGA Business Services

Tags: 
fast track approvals, orphan drugs
10 July 2019

Links to information on variations to prescription medicines

Tags: 
variations, chemical entities, biological medicines, generic medicines, manufacturing
ACM meeting statements which describe matters considered by ACM at each meeting
Tags: 
ACM, committee statements
4 August 2017

This guidance applies when GMP clearance is obtained by any pathway, or by GMP certification following a TGA inspection

Tags: 
manufacturing
1 October 2020

Information on TGA's biennial Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey

Tags: 
pharmacovigilance

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