Regulatory Pathways Supporting Expedited Drug Development And Approval In ICH Member Countries

By Pedro Franco, Ritesh Jain, Elizabeth Rosenkrands-Lange, Claudia Hey, and Marén U. Koban

Creating new drugs presents a formidable and intricate journey, marked by extended development schedules and a mere 10% success rate for compounds entering phase I clinical trials. This persists even in the face of numerous scientific guidelines, engagements with regulatory bodies, and the institution of specific review schedules by regulatory agencies across numerous nations. In an effort to hasten patient access to therapies, particularly in domains grappling with severe, life-threatening ailments and unaddressed medical requirements, numerous regulatory authorities worldwide have implemented pathways designed to fast-track drug development and clearance.

It is clear that the growing availability of accelerated regulatory pathways and the modernization of regulatory systems are reshaping the current regulatory landscape, necessitating sponsors to reevaluate their drug development and regulatory strategies. A shift in the current sequence of regulatory submissions is on the horizon, with a focus on countries or collaborations that possess the most efficient regulatory processes for swiftly delivering innovative medical treatments to patients in need.

This article examines the various routes for expediting drug development and approval in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as in Australia.