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.
18 Nov 2015
Evidence of GMP compliance for prescription medicines
This guidance is for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
1 Jul 2015
New guidance and forms
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.
- General dossier requirements - submitted after September 2013
For hard copy and electronic format
- General Dossier requirements- mandatory after 1 October 2015
For electronic formats. Hard copy not required
- Common Technical Document (CTD) overview
Overview of CTD structure and organisation
- CTD Module 1
Administrative information and prescribing information for Australia
- Australian eCTD submissions
Australian electronic Common Technical Document submissions
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.