Accelerating Global Access for Indication Extension Through Regulatory Reliance Pilot: The First Indication Extension...

Regulatory reliance pathways are increasingly being recognized as essential tools to accelerate patient access to medicines globally while building National Regulatory Authorities (NRA) capacity and capability. Although significant progress has been made in a number of international pilots for Chemistry, Manufacturing and Controls (CMC) post approval changes, there has been more limited application to labelling variations including indication extensions. This paper describes the first reliance pilot for an indication extension, which engaged 21 NRAs across multiple regions. The pilot leveraged the European Medicines Agency (EMA) as a reference agency and incorporated a digital platform, whose use was optional by the NRAs involved, for real-time sharing of questions and responses. The objectives were to reduce approval timelines, promote regulatory convergence, streamline health authority questions and enhance transparency among participating authorities. Results demonstrated significant reduction in approval timelines, with an average reduction of 3 months per country compared to standard timelines across participating countries. This article outlines the process of establishing the pilot, including planning and engagement with regulatory authorities, analysing success factors and challenges encountered including recommendations for optimising the process further. The findings suggest that regulatory reliance for indication extensions can substantially improve efficiency in regulatory processes, reducing approval timelines and ultimately benefiting a wider patient population to access medicines globally and timely.