For the first time, EMA has 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. These are:
- 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.
By publishing this list, the Agency seeks to stimulate researchers and funding organisations to consider addressing these topics in their research agendas and share their findings and results with regulators. 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.
Researchers and funders are invited to get in touch with EMA should they be interested in one of the topics on the list or the initiative in general. 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.