EMA proposes research on challenging regulatory topics, new research platform

The European Medicines Agency (EMA) has published an updated list of regulatory science research needs (RSRN) that it hopes will lead to better regulatory tools and practices. It also published a concept paper to create a European Platform for Regulatory Science Research to improve stakeholder discussions on regulatory science issues.

The EMA Regulatory Science Strategy to 2025, launched in 2020, included several initiatives to help the agency ensure its regulatory tools can keep up with scientific and medical advancements. The RSRN was created to identify those challenges and opportunities so that the agency can work on developing those tools. The first version of the RSRN was published in December 2021, some of which have been reincorporated in the updated list.

The new list addresses questions in four key areas, including how to improve clinical research in Europe, improve the evolution of the regulatory system, leverage technologies to help develop specific types of drugs, and advance veterinary medical regulations.

"By highlighting these research needs, the goals are to stimulate research in these fields; to encourage researchers to consider in their area of work the regulatory and public health challenges and opportunities; to help researchers identify topics of common interest for interactions such as in the EMA/HMA European Platform for Regulatory science research and for exploring with researchers pathways for translating results into solutions; and to offer the research needs for the awareness of funders so as to support their scoping of funding calls," said EMA. "The list of needs will be further evolved into a living document, updated periodically to ensure ongoing engagement as new topics are identified."

Between February and May 2024, EMA conducted 20 interviews with internal experts across 240 departments and workstreams to get feedback on their challenges, which was used to update the RSRN list. In total, the agency identified 109 priority topics and 49 research needs.

The RSRN is divided into four sections, including a section on research needs to improve clinical research. Some of the needs addressed include research on analytical methods for clinical trials, research methods to improve the efficiency of design and analysis methodologies for trials, and research on EU capacity and operational aspects of clinical trials.

The document also includes a section on research needs to improve regulatory system evolution. It includes nine research needs and 23 priority topics that are aimed at improving EMA’s regulatory methodologies, standards, and practices, which in turn is expected to improve the agency’s efficiency.

“This is expected to help maintain an adaptive and dynamic regulatory system that fosters growth and innovation, while ensuring public trust and reliability,” said the agency.

Alongside the RSRN, EMA also published a concept paper proposing creating a European Platform for Regulatory Science Research. The agency said the platform aims to improve collaboration between academic researchers and regulators across Europe and beyond.

“The aims of the European Platform for Regulatory Science Research are, advancing and accelerating regulatory science research, addressing regulatory science research questions and increasing the quality and impact of research to improve regulatory practices and medicines development, by promoting dialogue and fostering collaboration among academic regulatory science researchers and with regulators across Europe and beyond,” said EMA.

Stakeholders can comment on the proposed list of research needs and the concept paper creating the new research platform until 18 December.

Updated RSRN list

Concept paper

EMA proposes research on challenging regulatory topics, new research platform

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