The European Medicines Agency (EMA) is committed to maintaining a strong working relationship with European academics and researchers. Collaboration between the Agency and academia is necessary for the Agency to be prepared for future challenges and opportunities offered by advances in science and technology.

Collaboration between EMA with academia logo

Fee waiver for protocol assistance (scientific advice for orphan medicines)

Update: Applicants from the academic sector can receive free protocol assistance for developing orphan medicines, as of 19 June 2020.  

EMA offers this incentive to further encourage the development of medicines for rare diseases.

The fee waiver for academia is available to:

  • public or private higher education establishments awarding academic degrees;
  • public or private non-profit research organisation whose primary mission is to pursue research;
  • international European interest organisations (as defined in Regulation (EU) No 1290/2013). 

The applicant must be established in the European Economic Area. 

The applicant must neither be financed nor managed by private for-profit organisations in the pharmaceutical sector, nor have concluded any agreement with any pharmaceutical companies about sponsorship or participation in the research project in question. 

For more information, see Fees payable to the European Medicines Agency and the Decision of EMA's Executive Director: 

Framework for collaboration

The EMA Management Board adopted a framework for collaboration between EMA and academia in March 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 that 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 supporting action plan describes activities that EMA will undertake to implement the framework, including:

  • raising awareness on the support the Agency can offer;
  • seeking to better understand academics' and researchers' support needs;
  • providing education and training for these stakeholders.

EMA published the framework and the action plan in April 2017:

Involvement of academia in EMA activities

Academics and researchers participate in the work of the Agency in several ways, including:

Stakeholder engagement report 2017

EMA publishes an PDF iconannual report on its interactions with patients, consumers and healthcare professionals, academics and their organisations, incorporating both quantitative and qualitative data.

For previous reports, see Key documents for healthcare professionals.

Background to the framework for collaboration

EMA held a survey with academics and researchers in early 2016 to better understand existing interactions between European Union regulatory bodies and these stakeholders.

The survey report identified a need to raise awareness about regulators' roles and activities and strengthening the support they offer to academia:

During its June 2016 meeting, the Healthcare Professionals' Working Party (HCPWP) held a workshop dedicated to discussing the pillars of the framework. It identified opportunities for leveraging and enhancing existing education and training activities and strengthening communication.

Representatives of academia called for regulators to support independent research and proactively indicate priorities and a strategic research agenda in regulatory science.

For more information, see:

The framework of collaboration with academia is in line with EMA's overarching framework for stakeholder relations management:

More information

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