EMA launches the Regulatory Science Research Needs initiative

The European Medicines Agency (EMA) has for the first time issued a list of regulatory science topics that need further research to close gaps and improve medicine development and evaluation to enable access to innovative medicines for patients.

EMA has identified around one hundred specific topics in the Regulatory Science Research Needs list. These topics, and the initiative itself, emerged from the stakeholder consultations which underpinned the development of the Regulatory Science Strategy to 2025. EMA carried out interviews with chairs of its scientific committees and working parties, and also with external experts and opinion leaders from the principal stakeholder groups. 

For both human and veterinary medicines, the topics have been divided into four categories:

• integration of science and technology in medicines development
• collaborative evidence generation to improve the scientific quality of evaluations
• patient-centred access to medicines in partnership with healthcare systems
• emerging health threats and availability/therapeutic challenges.

EMA stated that, by publishing this list, it seeks to stimulate researchers and funding organisations to consider addressing these topics in their research agendas and share their findings and results with regulators. Moreover, EMA added that, by engaging in the Regulatory Science Research Needs initiative, researchers and funders will be able to see their findings translated into regulatory practice, medicines development and public health. The list will be also updated periodically with new topics and references to related research. 

“The acceleration of innovation in medicines development requires a parallel advancement in regulatory science,” EMA claimed in the report. “New technologies and evolving science throw up new regulatory questions and it is important that these questions are answered so that innovation is translated safely and swiftly into effective, high-quality therapies.

“Addressing the research needs in regulatory science requires a collaboration with both academia and key research funding bodies. While EMA may be able to fund a small portion of the research needs, external funding obtained by researchers will remain the primary pathway for addressing the research topics. To this end, EMA is committed to fostering a strong working relationship with European academicians and researchers as well as key research funding bodies, as part of the EMA’s Academia Action Plan,” the report continued.

A webinar to inform patients, academic and collaborative research groups, and health professionals is planned on 18 January 2022 to explain the Regulatory Science Research Needs initiative and how stakeholders can engage with it.