Research projects

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This page lists the main research projects that the European Medicines Agency is involved in, as part of its support to research with academia, learned societies and research groups. 

Many of the research projects that the Agency is involved in form part of the Innovative Medicines Initiative (IMI). This is Europe's largest public-private initiative, which aims to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe.

Table of contents

Improving regulatory and methodological standards

Strengthening the monitoring of benefits and risks

The Agency coordinates the IMI project Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT). PROTECT is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance, made up of a multinational consortium of academics, regulators and pharmaceutical companies.

PROTECT is divided into a number of work packages, concentrating on topics such as:

  • establishing a framework for pharmacoepidemiology studies;
  • improving signal detection from spontaneous reports, electronic health records and clinical trials;
  • examining the use of medicines by pregnant women;
  • developing graphical representations of the benefits and risks of medicines.

Agency staff have also contributed to:

Regulatory science

The Agency is a key leader in the development and application of regulatory science, the areas of science that are used in the assessment of the quality, safety and efficacy of medicines throughout their life-span, as well as the scientific areas used in regulatory decision-making.

Regulatory science includes basic and applied biomedical sciences, including genetics, pharmacology, biostatistics, clinical-trial methodology and epidemiology, and social sciences such as decision sciences, risk assessment and communication sciences. It aims to contribute towards the development of standards and tools to be used in the regulation of medicines.

The Agency is taking part in a number of projects, including a collaborative research project with the Massachusetts Institute of Technology (MIT) focusing on enhancing regulatory science in pharmaceuticals and organised a conference called Regulatory science: are regulators leaders or followers? in December 2010.

The Agency also takes part in activities of the Council for International Organizations of Medical Sciences (CIOMS), an international, non-governmental, non-profit organisation established in 1949. CIOMS aims to facilitate and promote international activities in the field of biomedical sciences. The Agency takes part in:

Adaptive licensing

Adaptive licensing is an approach to the authorisation of medicines that is currently being discussed and developed. In this model, licensing is based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach could allow approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The Agency is conducting a pilot project to help develop an understanding of how future adaptive licensing pathways might be designed for different types of products and indications. The pilot project builds on earlier work with the Massachusetts Institute of Technology’s Center for Biomedical Innovation (CBI) to investigate the feasibility of this approach.

Benefit-risk methodology

The Agency is working on a project to develop standard decision-making methodologies to make the assessment of the benefits and risks of medicines more consistent, more transparent and easier to audit. Until the end of 2011, this was carried out together with experts in decision theory from the London School of Economics and Political Science (LSE) and with the University of Groningen.

Addressing failure rates in medicine development

The Agency and the Netherlands Medicines Evaluation Board are working on a project to analyse the failure rate of innovative drugs in the current regulatory system, focusing on delivering evidence and credibility for regulatory reform and policy recommendations. The project forms part of the Escher project, which brings together experts from Utrecht University and partners from the pharmaceutical industry. This project aims to assess the extent to which the following aspects are associated with marketing-application failure:

  • the design and different phases of the development plan;
  • the clinical outcome;
  • clinical relevance.

Improving risk communication on medicines

As part of its commitment to improving communication with its stakeholders on the benefits and risks of medicines, the Agency invited Dr Frederic Bouder, an independent expert from King's College London, to carry out a study looking into the expectations and attitudes of the Agency's stakeholders on its communication activities, which was finalised in 2011:

Bringing expertise together

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The Agency plays a key role in forming and managing networks, bringing together expertise and enabling knowledge sharing. It has launched and manages two major such networks:

  • European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), a network of excellence in collaboration with European academics to improve the independence, transparency and research standards in the field of post-authorisation research, particularly observational research. Its goal is to further strengthen the post-authorisation monitoring of medicines in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on the benefit-risk balance, using available expertise and research experience across the EU;
  • European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA aims to foster high-quality ethical research on the quality, safety and efficacy of medicines to be used in children. It does this through networking and stakeholder collaboration with members from within and outside the European Union (EU).

The Agency also takes part in Patient Registries Initiative (PARENT) Joint Action, which aims to support EU Member States in developing comparable and coherent patient registries in fields of identified importance such as chronic diseases, rare diseases and medical technology. It intends to rationalise and harmonise the development and governance of patient registries, enabling analyses of secondary data for public-health and research purposes. The project, which is partly funded by the European Commission, began in May 2012.

Helping to set the research agenda

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The Agency is ideally placed to identify research questions linked to regulatory sciences and public-health issues linked to medicines.  

The Seventh Framework programme (FP7) is a funding tool managed by the European Commission's Directorate-General for Research and Innovation (DG RTD). It provides funding for research in many areas, including health-related topics such as infectious diseases, personalised medicines and public health. Each year, the Agency provides recommendations to DG RTD on the types of research where funding should be made available, which may be the subject of open calls and may result in research being funded by the FP7:

The Agency also collaborates internationally with other regulatory agencies, such as the United States Food and Drug Administration (FDA) and Health Canada. For example, in 2011 the Agency hosted a Joint workshop on progressive multifocal leukoencephalopathy (PML) with the FDA, leading to the establishment of a joint PML research agenda. PML is a rare, debilitating and sometimes fatal disease that is characterised by progressive damage to the white matter of the brain. It is caused by the JC virus. PML can occur in different conditions that affect immune response and it has been identified as an adverse drug reaction to some medicines that affect immunological functions.

Improving medicines for children

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The Agency is involved in two work packages of the Global Research in Paediatrics – Network of Excellence (GRIP) project, an FP7-funded project that aims to improve the health of children globally, by stimulating and facilitating the development and safe use of paediatric medicines:

Investigating vaccines

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Representatives of the Agency lead or take part in a number of projects looking at the development, benefits and risks of vaccines. These include:

For more information on the ADVANCE project, see Launch of European project for monitoring benefits and risks of vaccines throughout their lifecycle.

Addressing antimicrobial resistance

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The Agency is concerned about the development of antimicrobial resistance, particularly resistance to antibiotics. It works in collaboration with its European Union (EU) and international partners in a number of initiatives aiming to limit the development of resistance. These include:

Since 2010, the Agency has also been leading a project collecting information on the sale of veterinary antimicrobials across the EU since 2010 called the European Surveillance of Veterinary Antimicrobial Consumption.

Advising and observing projects

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The Agency has an advisory role in a number of other projects. These include:

The Agency also acts as an observer for projects, including:

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