EMA - Public consultation - list of enabling tools

14th November 2024

EMA - Public consultation - list of enabling tools

The European Medicines Agency has published for public consultation a revised list of enabling tools: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/revised-list-enabling-tools_en.pdf
Enabling tools are defined as novel technologies that have the potential to enable innovation and impact medicine development. As part of EMA’s horizon scanning and foresight activities, applicants to EMA procedures are asked to highlight the enabling tools applied in their development programs. This information is requested when registering a Research Product Identifier (RPI) in IRIS (an EMA platform for submitting applications electronically).

Following an analysis of the list of enabling technologies in 2023 and previous years, the EMA is updating the list of enabling technologies to better capture innovative features of proposed developments discussed.

Comments should be provided by 30 November 2024 using this EU survey: https://ec.europa.eu/eusurvey/runner/654b272a-a252-57b2-f8bc-16a27cbdf70f

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