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.


Updates

1 Aug 2017

Electronic designation application form

The electronic designation application form is now available on TGA Business services. For more information see our guidance

29 Jun 2017

Minor variations to prescription medicines

Guidance on how to make minor variations to prescription medicines

26 Jun 2017

Priority review pathway: prescription medicines

Implementation of a Priority review pathway for the registration of novel prescription medicines

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.