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.
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
Information about the prescription medicines registration process in Australia.
- Overview: Prescription medicines registration process
Requirements, phases and milestones
- Mandatory requirements
Requirements for an effective application
- Fees and charges
Introduction to TGA fees and charges
Prescription medicines forms for applicants and sponsors.
- Pre-submission Planning Form (PPF)
- CTD Module 1 forms
- Forms for minor variations to registered prescription medicines
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
The information on this website is available in PDF and Microsoft Word format for printing.
These guidance provide information about specific technical requirements and particular types of medicine.