Information for you
On this page, you will find information on the Agency’s activities that are most relevant to patients and carers, including news, and events.
You can contribute to the Agency’s work by responding to public consultations.
Learn more about how Patients and carers are actively involved in the work of the Agency.
EMA held a workshop in March 2017 on the challenges and opportunities for personalised medicines and the role of patients and healthcare professionals. The workshop discussed policy developments in Europe and globally, the contribution of the European medicines regulatory network and how clinical practice and public participation can support personalised medicine. EMA will publish the presentations, video recording and a workshop report on the event page.
Working parties' joint meeting
A joint meeting between the Healthcare Professionals’ Working Party and the Patients' and Consumers' Working Party in March 2017 discussed interactions between EMA and these stakeholders in 2016, the working parties’ annual work plans for 2018-19 as well as the outcome of the CHMP pilot project on patients’ involvement. It also included presentation on European Antibiotic Awareness Day, and activities on biosimilars at EU level. EMA will publish all presentations on the event page and will also publish an annual report on its interactions with these stakeholders in 2016.
Getting involved as an individual expert
Patient experts contribute their real-life experience of living with their condition directly into scientific regulatory discussions. Primarily, EMA contacts experts via its network of eligible organisations. Individuals interested in working with EMA can also be included in the individual experts' stakeholder database, by completing the online registration form. More information on the database can be found in a question and answer document.
EMA held a stakeholder workshop in October 2016 to better understand the challenges and barriers to collaboration between stakeholders on patient registries. The Agency published a workshop report in February 2017, which recommends activities for EMA to undertake to improve stakeholder collaboration and optimise the use of registries to support regulatory decisions.
Small-population research methods and regulatory application
EMA held a workshop in March 2017 on three projects funded by the EU, Asterix, IDeAl and InSPiRe, to develop new methodology on design and analysis of small population clinical trials since 2013. The workshop aimed to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalised medicine.
News for patients and carers
European Immunisation Week: Statement of Guido Rasi, the Executive Director of the European Medicines Agency (EMA)
"We all have to fight vaccine fears to win the war against resurging, vaccine-preventable diseases." ... Read more
Eleven medicines recommended for approval, including four orphans ... Read more
Brineura reviewed under accelerated assessment ... Read more
Update completes previous recommendations issued in March 2017 ... Read more
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Events of interest
The European Medicines Agency (EMA) launched the PRIME (PRIority Medicines) scheme in March 2016. The scheme provides early and enhanced support to medicines that have the potential to address patients’ unmet needs. This meeting is organised by EMA to review the experience gained with PRIME one year after it was launched. The aim of the meeting is to receive feedback from users and potential users of the scheme, provide information on how the rules on eligibility have been applied and what types of support applicants have received so far and discuss practical examples that illustrate the benefits of PRIME and how it builds on the existing tools. ... Read more
29/03/2017 - 30/03/2017
Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop
The European Union funds three projects, Asterix, IDeAl and InSPiRe, within the Seventh Framework Programme (FP7) to develop new methodology on design and analysis of small population clinical trials since 2013. The projects are in their final phase. The workshop will discuss their results to date. The aim is to translate and promote results and novel methodologies into tangible recommendations to advance the clinical research and development of medicines and new treatments for patients with a rare disease and personalised medicine. The results to date and draft recommendations for application will be discussed by international representatives of patient organisations, pharmaceutical industry, academic statisticians and clinical trial methodologists, clinical researchers, pharmaceutical industry and regulators. ... Read more
05/12/2016 - 06/12/2016
In January 2016 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted a strategy for measuring the impact of pharmacovigilance activities performed at European Union (EU) and Member States level which relies on a collaborative approach of all stakeholders. Measuring the impact of key pharmacovigilance activities will allow regulators and stakeholders to determine which activities are most successful and to identify enablers and barriers for generating positive health impacts which will contribute to the further development of proactive pharmacovigilance systems and to promote best practice across the EU. The aim of this workshop is to facilitate the implementation of the PRAC strategy with a particular focus on the development of methodologies and the fostering of collaboration. ... Read more
The workshop brings together experts and stakeholders from the academic, regulatory and industrial sectors to discuss key issues and new developments in the field of development of antimycobacterial medicines to treat tuberculosis. The presentations and discussions support the finalisation of the newly drafted addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to mycobacterium tuberculosis. The workshop will be broadcast live. ... Read more
Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines
The European Medicines Agency (EMA) held a public consultation a concept paper which outlined the major areas for revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’, from July to September 2016. Subsequently, EMA published a draft revised guideline for public consultation, from November 2016 to February 2017. This technical workshop aims to finalise the guidance with further involvement of stakeholders including from other regulatory agencies, pharmaceutical industry, contract research organisations and academia. The focus of the workshop will be on discussing comments received during the public consultations, therefore participation of external stakeholders is limited to those individuals and organisations who submitted comments. The output of the workshop will be reflected in the final revised guideline and the published overview of comments. ... Read more
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