You are here

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

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
6 March 2020

Information to assist sponsors with reformatting their approved PI or preparing a new PI in the required format

Tags: 
product information, variations
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
9 August 2013

Guidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer

Tags: 
variations
4 October 2019

Data requirements for formulation changes to inhalation and nasal spray medicines

Tags: 
generic medicines, variations
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
19 January 2018

The prescription medicine notification process

Tags: 
variations

Pages