Guidelines for Prescription Medicines
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.
15 December 2019
Evidence of GMP for prescription medicines
Guidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
8 February 2019
Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances
Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allow discretion to reduce application and evaluation fees for a major variation application in exceptional circumstances
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 variations to prescription medicines – excluding variations requiring the evaluation of clinical or bioequivalence data
CTD and general dossier requirements
Information about hard copy and electronic submission dossier formats.
- General dossier requirements
For electronic formats.
- Common Technical Document (CTD) overview
Overview of CTD structure and organisation
- CTD Module 1
Administrative information and prescribing information for Australia
- Electronic submissions
Guidance on electronic 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.