Regulatory science research needs

The European Medicines Agency (EMA) has identified around one hundred topics where research is needed to address knowledge gaps in regulatory science. Research in these areas can support medicine development and evaluation, ultimately helping patients in the European Union (EU) access innovative medicines that address their needs.

A list of regulatory science research needs is available from EMA, capturing these topics. 

By making this list available, EMA hopes to encourage researchers and funding organisations to address these needs in their work and programmes.

EMA will maintain the list over time by including new topics and references to relevant research. 

Regulatory Science - Research needs

Reference Number: Version 1.0

Interactive webinar

EMA will host a live interactive webinar for researchers and research funders on 18 January 2022, to introduce the list of regulatory science research needs and answer questions.

For more information and to register, see:

• Research in regulatory science – addressing the needs (18/01/2022)

Benefits of addressing the research needs

Addressing the research needs will help advance regulatory science to keep pace with evolving technologies and improve patient access to innovative medicines.

The regulatory science research needs reflect public health needs based on regulatory experience. Generating knowledge to close any of these research gaps can have a direct impact on public health by supporting the regulation of medicines in the EU, including the development of scientific guidelines and decision-making processes in EMA's scientific committees.

Researchers and research funders addressing these regulatory science research needs will gain opportunities including the following:

• Translating research results into regulatory practice through informing scientific guidelines, impacting medicine development programmes and benefiting public health
• Disseminating research results through EMA events, discussion and joint publications with regulatory scientists in the European medicines regulatory network
• Contributing to scientific evaluations and discussions on specific medicinal products, ATMP qualifications or scientific guidelines 
• Influencing the EU research agenda by supporting the maintenance of the list of regulatory science research needs over time

Background and context

The regulatory science research needs draw on a stakeholder consultation process underpinning EMA's Regulatory science strategyto 2025. 

To develop the strategy, EMA interviewed the chairs of its scientific committees and working parties, external experts and stakeholders. Many identified specific knowledge gaps in the field of regulatory science.

EMA drew up a list of research needs on this basis and validated it in 2021 with its academia collaboration matrix, Healthcare Professionals' Working Party and scientific committee chairs, producing a list of around one hundred research topics covering human and veterinary medicines. 

Contact point

If you are a researcher or research funder, please get in touch with EMA if you wish to:

• make general comments on the regulatory science research needs list or a specific topic on the list;
• share details of planned, ongoing or finalised research concerning a topic on the list;
• recommend a topic not on the current list. 

Please email [e-mail] mentioning 'RSRN' in the subject line and the specific research question number (e.g. 'H.1.1.1') if relevant. The list includes mailto links with pre-filled subject lines to facilitate contact.