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.
10 May 2018
Inhalation and nasal spray registered medicines
New information about application pathways and data requirements for inhalation and nasal spray registered medicines
23 Mar 2018
New and updated forms guidance
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
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.