Recital 17

(17) The activation of emergency research and innovation plans, as well as the repurposing of medicinal products and the activation of clinical trial networks, and conduct of clinical trials, should be ensured to reduce any delays in the development phase of crisis-relevant medical countermeasures. Research and innovation activities should be able to use European digital infrastructures as well as platforms operating under the European Open Science Cloud and other accessible EU digital platforms, in order to get access to (real-world) data for quick analysis. Close coordination of the Commission with the ECDC and the EMA, as the Agency responsible for scientific advice and scientific assessment of new and repurposed medicinal products, should be ensured for those matters, as well as for those related to regulatory aspects concerning the authorisation of medicinal products, including for the establishment of new manufacturing sites for authorised medicinal products, and to guarantee the acceptability of the clinical trials and the evidence they generate for the authorisation of new or repurposed medicinal products. Emergency research can also include diagnostic preparedness. That should allow key actors and relevant infrastructure to be immediately ready for operation in times of public health emergencies, thereby reducing any delays.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.