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.


23 Mar 2018

New and updated forms guidance

New: Completing a designation or determination extension application form in TGA Business Services


Updated: Completing a determination or designation application form in TGA Business Services

21 Mar 2018

Provisional approval pathway: prescription medicines

Implementation of a Provisional approval pathway for the time limited registration of eligible prescription medicines

21 Mar 2018

Electronic designation-determination application form

The electronic designation/determination application form now extends to provisional determination

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.