Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.


24 Sep 2014


Updated Pre-submission Planning Form (PPF) to include a hyperlink to orphan drug designation.

08 Jul 2014

Guidance 15 Biopharmaceutic studies

Updated specific guidance to replace the former appendix 15 is now available.

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Subscribe to updates to receive an email alert when TGA guidance is updated.

Prescription medicines registration basics

Information about the prescription medicines registration process in Australia.

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CTD and general dossier requirements

Information about hard copy and electronic submission dossier formats.

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Print version

The information on this website is available in PDF and Microsoft Word format for printing.

Specific guidance

These guidance provide information about specific technical requirements and particular types of medicine.

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