Posted by Michael Wonder on 26 Jun 2017
Priority review pathway: prescription medicines
26 June 2017 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), the TGA is implementing a priority review pathway for the registration of novel prescription medicines for Australian patients.
Priority review will involve faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. The priority review pathway will require new and flexible business processes in order to facilitate faster assessment for registration, while maintaining TGA's high standard for efficacy, safety and quality.
