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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.

Sponsors may now apply to register a prescription medicine under the provisional approval pathway, priority review pathway or the standard prescription medicines registration pathway.


Updates

6 June 2018

Electronic submissions update

Reminder that the transition period for current Australian regional specification ends 30 June 2018

10 May 2018

Inhalation and nasal spray registered medicines

New information about application pathways and data requirements for inhalation and nasal spray registered 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.