The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
This guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either:
- register an OTC medicine in the ARTG
- vary the safety and/or efficacy aspects of a registered OTC medicine.
For guidance on how to present clinical efficacy and safety data in the CTD format, see:
- CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: EU Module 5 - Clinical Studies (CPMP/ICH/2887/99 Rev 1 Efficacy)
- CTD for the registration of pharmaceuticals for human use - Nonclinical overview and nonclinical summaries of Module 2 and organisation of Module 4: EU Module 4 - Nonclinical studies (CPMP/ICH/2887/99 Rev 1 Safety)