Marco Righi -

In December 2021, the European Medicines Agency (EMA) published a list of regulatory science topics that require further research efforts to address the current medical needs and improve medicinal drug development and evaluation with the goal to increase the number of available innovative medicines for the patients.

For both human and veterinary medicines, EMA has identified around one hundred specific topics in the Regulatory Science Research Needs list. (link), 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.

By publishing this list, which will be updated periodically with new topics and references to related research, EMA has the intention to further stimulate the synergy between researchers, funders and regulators in order to trigger a quick translation of the obtained scientific findings into regulatory practice, medicines development and public health.

“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”.

A webinar to further explain how stakeholders can engage with the Regulatory Science Research Needs has been planned by EMA on 18 January 2022.

Regulatory Pharma Net (RPN) has successfully supported companies in the optimization of the drug development strategies including assistance in the Scientific Advice procedure. RPN is ready to provide support and prompt updates about any new initiative launched by the authorities.

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