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Academia

EMA
2026/03/24

Academia

EMA is committed to a strong working relationship with European researchers and developers from the academic sector.

Academia plays an important role in advancing medicines and improving health systems through research.

EMA is fostering interactions between academics and European Union (EU) regulators. This helps to increase understanding of the regulatory environment.

EMA is also using various regulatory services to support academia deliver high-quality research and medicines.

Academia stakeholders that EMA is working with include:

  • Universities, other public or private not-for-profit organisations or higher education establishments
  • Consortia funded under public research programmes
  • Individual researchers pursuing research independent from commercial control

Areas of collaboration include regulatory science research, clinical trials, oncology, quality of medicines, advanced therapy medicinal products and medicine repurposing.

For more information on EMA's work with its partners and stakeholders, including healthcare professionals, see:

Also on this topic

Regulatory and scientific support

EMA provides regulatory and scientific support for the development of medicines, from the early phases of research in the laboratory all the way to the patient.

The support for academic researchers and developers covers topics such as:

  • New or innovative medicines
  • Repurposing of medicines
  • Advanced therapies
  • Drug development tools
  • Novel methodologies
  • Clinical trials and research methods
  • Regulatory science research projects
  • Pre-competitive consortia or partnerships
  • Involvement with externally funded projects

Researchers and developers can use the EMA services listed below:

  • Academia briefing meetings
  • Innovation Task Force briefing meetings
  • Scientific advice and protocol assistance
  • Qualification of novel methodologies
  • Regulatory science research support
  • PRIME scheme

For more information, see:

Academia briefing meetings

EMA offers academia briefing meetings with researchers and developers through its regulatory science and academia workstream.

This is an exchange of information enabling mutual understanding and engagement on challenges and research issues. It helps advance research and development activities and capacities. It also facilitates discussion on scientific plans and regulatory aspects.

Briefings are free of charge and require only minimal preparation. Researchers interested in attending EMA's academia briefing meetings are welcome to contact [email protected].

EU Members States also offer support to academia. More information is available via a 'map' of national support initiatives findable on the dedicated website of the 'Accelerating Clinical Trials in the EU' project: Accelerating Clinical Trials: Map of national support initiatives.

Scientific advice: fee reduction and training

Fee reductions for scientific advice

EMA can provide scientific advice fee reductions for certain not-for-profit entities. These reductions also cover qualification advice and protocol assistance.

They are meant to further encourage researchers and developers from the academic sector to contribute to public and animal health.

This are in line with the Fee Regulation (Regulation (EU) 2024/568) which entered into force on 1 January 2025.

In order to grant a fee reduction, EMA has to verify compliance with the Fee Regulation working arrangements.

EMA needs to receive verification requests at least 5 weeks before requests for scientific advice.

The verification must be completed with a positive outcome (i.e. compliance verified) by the time of submission of the request for scientific advice, at the latest.

For more information, see the Fee Regulation working arrangements, section “1.8. Entity not engaged in an economic activity (Annex V.2)”.

To ask for a verification, complete the application form below and send it to [email protected]:

Verification application form

Reference Number:

EMA/557970/2024

English (EN) (136.31 KB - DOCX)

First published:

03/09/2025

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Other types of EMA support

EMA can also offer fee reductions for:

  • small and medium-sized enterprises (SMEs)
  • advanced therapy medicinal products (ATMPs)
  • orphan-designated medicinal products
  • medicines for paediatric use
  • public health emergencies and imperative reasons

For more information, see:

Training support on scientific advice

Training is available for academic researchers and developers to align their research with regulatory expectations.

The training also provides guidance for them to generate robust evidence in support of medicine development.

It includes information on the following:

  • How to write a strong briefing document
  • How to formulate regulatory questions and positions
  • How to interpret responses received

The training also features information on other support tools such as qualification of novel methodologies, and academia and Innovation Task Force (ITF) briefing meetings.

It is available in both video and PDF format. EMA developed this training together with European Infrastructure for Translational Medicine (EATRIS).

How to apply and benefit from scientific advice - Training for academic medicine developers

English (EN) (9.52 MB - PDF)

First published:

04/03/2026

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For more information, see:

Engagement on regulatory science research

EMA works across a broad range of topics with a broad range of stakeholders to improve the science and process of medicines regulation.

Stakeholders include universities, research institutes, public-private initiatives, the European Commission, EU Member States and international organisations.

Our activities range from acting as the secretariat for multi-partner networks to partnering in European and international research projects.

You can address related questions to [email protected].

Support for consortia and externally funded projects

EMA may provide support to developers and researchers applying for funding.

It can engage in externally funded pre-competitive projects. For example, EMA can contribute expertise in an advisory role or as a consortium partner.

For competitive applications, EMA typically cannot decide on any involvement but may be able to comment on related text in draft grant applications. Grant applications should include milestones and budgets for using regulatory and scientific support services.

EMA offers collaboration management meetings with consortia, public-private partnerships and externally funded projects through its regulatory science and academia workstream. This facilitates project understanding, partners and outputs, flagging opportunities for addressing scientific and regulatory challenges in research projects as well as exploring potential interactions and collaboration.

EMA recommends applicants to consider in particular the regulatory science research needs. EMA continually identifies gaps in regulatory science. It encourages researchers from academia and industry as well as funders to address these needs in their work, grant applications, consortia and programmes.

Workplans of relevant EMA committees and working parties, reports on public events at EMA and scientific publications by EMA staff members are also relevant sources for applicants.

For more information on EMA's involvement in externally funded projects, how to engage with regulators, and EMA's work on regulatory science research, see:

European Platform for Regulatory Science Research

This platform brings together academia and regulators.

Topic discussions in the platform seek to facilitate scientists from academia and industry to move their research forward and to translate it for regulatory science.

EMA and the Heads of Medicines Agency (HMA) launched the platform in March 2025.

For more information, see:

Exchange of expertise

Select the expandable panels below to find out how EMA taps into the expertise of academics and experts, and makes expertise available to young researchers and students:

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Individual academics

If you are an individual academic, you can contribute to EMA activities as a specialist in your area.

You can register your interest to be included in the EMA’s individual stakeholder database by completing the online registration form listed below.

By self-registering and specifying your areas of expertise, you enable EMA to send targeted emails.

In the online registration form below, include your area of regulatory science research into the field “Other (specify)”.

To register and get involved, see:

European experts

EMA and EU Members States from national competent authorities or from academic institutions can nominate European experts to contribute to EMA activities.

These experts may serve in EMA's scientific committees, working parties, shortages steering groups, Emergency Task Force and other groups.

They can also get involved in EMA's work on one or more medicinal products for human or veterinary use.

European experts have to submit a declaration of interests (DoI) every year. This declaration flags financial or other interests in pharmaceutical or medical device companies that could affect their impartiality.

EMA may invite individual academics to serve as European experts.

For more information, see:

Collaborating experts

EMA can host collaborating experts interested in collaborative research projects related to EMA’s scientific work. This work includes the research needs made public.

EMA regularly posts vacancy notes for collaborating experts.

In addition, EMA is open to proposals for collaborative research projects, in line with its Policy 83 on visiting and collaborating experts.

For more information and to sign up for notifications, see:

Young researchers and professionals

EMA encourages young researchers and professionals interested in EMA's work to explore our ten-month traineeship programme.

This is an opportunity for recent graduates to learn new skills and seek a valuable work experience.

For more information and to sign up for notifications, see:

Students

Students and all those interested in EMA for educational purposes can use EMA’s learning material listed below.

EMA makes relevant training available on its EU Network Training Centre webpage. This includes the Clinical Trials Information System (CTIS), pharmacovigilance and EudraVigilance.

Recordings on topics and events such as EMA info days for academia and SMEs and EMA's 30th anniversary scientific conference are available on EMA's YouTube channel.

Visits of student groups at EMA are generally not possible.

For more information, see:

Clinical trials

EMA can answer questions on the conduct and use of clinical trials via its regulatory and scientific support.

The Accelerating Clinical Trials in the EU (ACT EU) initiative supports non-commercial trial sponsors to identify gaps, issues and bottlenecks that prevent them from setting up and conducting clinical trials, in particular multinational trials.

A helpdesk is available with tailored technical assistance on the functionalities of the Clinical Trials Information System (CTIS). It addresses questions on regulatory requirements related to the clinical trial lifecycle.

An interactive map also details the various national initiatives supporting non-commercial sponsors at national, EU or global level.

In addition, ACT EU also set up a multi-stakeholder platform with the aim of improving the clinical trials environment through collaboration.

Training resources are also available.

For more information, see:

Oncology

EMA's Cancer Medicines Forum aims to help advance research into optimising cancer treatments and foster high standards in cancer care in the European Union (EU).

EMA set up the forum in March 2022. It co-chairs the forum together with the European Organisation for Research and Treatment of Cancer (EORTC).

In addition, EMA and the Heads of Medicines Agencies (HMA) conducted a pilot project to enable clinical oncology scientists to participate in medicine regulation.

The pilot focused on scientific advice and marketing authorisation assessments for human medicines. It was completed in September 2024.

For more information, see:

Quality of medicines

EMA's Quality Innovation Group (QIG) holds focus group meetings with stakeholders from industry, academia and international regulators.

These meetings enable EMA to learn about the regulatory challenges developers face in relation to innovative products, processes, control strategies and facilities. They also help identify potential solutions by working collaboratively.

For more information, see:

Advanced therapy medicinal products

EMA tested offering increased support to academic and non-profit developers of advanced therapy medicinal products (ATMPs) in meeting regulatory requirements. It did so via a pilot launched in 2022. Several projects included in the pilot continue to receive support.

EMA also makes available a comprehensive set of regulatory, scientific and procedural guidelines for developers of ATMPs.

For more information, see:

Medicine repurposing

EMA and national competent authorities (NCAs) carried out a pilot project offering tailored scientific advice to not-for-profit organisations and academic developers on repurposing authorised medicines for new indications.

EMA and Heads of Medicines Agency (HMA) conducted the repurposing pilot between October 2021 and December 2024.

They remain committed to supporting the repurposing of authorised medicines. This includes:

• Academia briefing meetings • Scientific advice, which EMA and NCAs can offer free of charge for eligible not-for-profit organisations • Facilitating discussions between regulators, academia and pharmaceutical industry

For more information, including a pilot report, see:

EMA academia collaboration matrix

EMA's academia collaboration matrix is an internal structure that provides governance and oversight for academia-tailored initiatives.

The academia matrix convenes EMA staff members. It engages in the following activities:

  • Developing and promoting best practices for effective interaction with academic researchers and developers
  • Streamlining engagement and support processes
  • Offering a venue to identify regulatory hurdles and develop effective solutions in support of academic researchers and developers - in particular those working at different stages of the medicine lifecycle

The matrix delivered on its first action plan, for 2021-2023, in five areas identified in EMA's Regulatory Science Strategy to 2025. EMA is preparing a follow-up action plan.

Academia collaboration matrix action plan 2021-2023

Reference Number:

EMA/159144/2021

English (EN) (224.02 KB - PDF)

First published:

30/04/2021

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For more information, see:

Framework for collaboration

EMA has a framework for collaboration with academia since 2017. This aims to:

  • raise awareness of EMA's role within the European medicines regulatory network;
  • promote and further develop regulatory support for translating academic research into novel methodologies and medicines;
  • ensure the best scientific expertise and academic research is available to inform regulatory decision-making;
  • collaborate on areas of research on regulatory science, such as novel approaches, endpoints and methodologies.

The framework is in line with EMA's overarching framework for stakeholder relations management.

Framework of collaboration between the European Medicines Agency and academia

Adopted

Reference Number:

EMA/125511/2017

English (EN) (262 KB - PDF)

First published:

03/04/2017

Last updated:

03/04/2017

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Framework of collaboration between the European Medicines Agency and academia - Annex I – Action plan

Adopted

Reference Number:

EMA/58661/2017

English (EN) (111.9 KB - PDF)

First published:

03/04/2017

Last updated:

03/04/2017

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For more information, see:

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

See update history

24 March 2026

Section on 'Scientific advice: fee reduction and training' updated to include video and PDF guidance for medicine developers.

Related information material

Video: How to apply and benefit from an orphan drug designation

Related content

External links

Related EU legislation

Contact point

[email protected]

Summary

The European Medicines Agency (EMA) partners with academia to adapt to advances in science and technology. Areas of collaboration include regulatory science research, clinical trials and oncology.