Consequently, Europe’s ability to approve innovative medicines efficiently and rapidly to the market is reduced, resulting in delayed access for European patients. The development, submission and/or regulatory review of innovative medicines is accelerated by ERPs, but use of this regulatory toolbox in Europe is limited compared to other regions. EFPIA welcomes the ongoing reflexion on a future-proofed regulatory framework for ERP, and beyond. Innovative Licensing and Access Pathway ‘ILAP’ with project ORBIS) can deliver faster access to new therapies by remaining in the global first wave to innovation while helping to manage resource capacity and expertise. Furthermore, ERPs adding work-sharing processes or collaborative platforms (e.g. In recent years, ERPs have expanded worldwide (Real-time Oncology Review ‘RTOR’ and Regenerative medicine-advanced Therapy Designation ‘RMAT’ in US, China, Australia…) to better support development and improve the speed and efficiency of regulator review of new technologies. ERPs can be considered a ‘regulatory toolbox’ that can be leveraged to best support the development and efficient assessment of important innovative treatments, so patients can receive them in a timely manner. Expedited regulatory pathways (ERPs) were developed by multiple international authorities to respond to these needs, creating enhanced early and frequent interactions to support and facilitate innovative treatment development and rapid processes to increase efficiency and reduce time both in development and subsequent regulator assessment. Some medicines benefit from increased support, such as enhanced regulator interactions, due to the level of complexity in development or unmet medical need and/or the ethical urgency with which a treatment should be integrated into best standard of care. Evidence generation also continues long after the first registration of a new medicine. Nadège Le Roux, Senior Director Regulatory Policy & Intelligence at Bristol Myers SquibbĮvidence generation for innovative medicines requires a global approach, both now and in the future, to meet regulatory requirements around the world. Leveraging this opportunity to enhance and future proof expedited regulatory pathways is essential to ensure the European regulatory framework can continue to support the development and regulatory approval of innovative medicines." " The revision of the pharmaceutical legislation is a once in a generation opportunity.
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