A11 – GMP Clearance Requirements for OTC Medicines

The TGA are finalising the updated processes and monitoring systems for OTC medicines based on a risk based framework. As part of this reform, there have been increasing expectations of the OTC manufacturers compared with past requirements. This session will explain the updated TGA processes with emphasis on the changes to the GMP requirements for OTC medicines, how they differ to the prescription medicines requirements, and existing international collaborations from both the TGA perspective and Industry perspective.


Chairperson: Jessica Keast, Scientific Affairs Consultant, The SPD Company