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.
Human medicines highlights for 2016
EMA has released an overview of its key recommendations in 2016 on the authorisation of new medicines. EMA recommended 81 medicines for marketing authorisation. This includes recommendations for 27 new active substances.
Patients’ and consumers’ working party elects co-chair
EMA’s Patients’ and Consumers’ Working Party has elected Kaisa Immonen as its new co-chair. Kaisa Immonen holds a Master of Arts in international relations and conflict analysis from the University of Kent in the United Kingdom. She has eight years’ experience in European Union health policy. Ms Immonen replaces David Haerry of the European AIDS Treatment Group, whose mandate has come to an end
10-year anniversary of PCWP
The Patients’ and Consumers’ Working Party (PCWP) celebrated its 10th anniversary with a series of events in 2016 including an anniversary meeting on 14 June, which reflected on how the involvement of patients in EMA activities has evolved since the creation of the Agency and discussed future priorities and challenges. EMA has published an anniversary webpage, featuring videos and articles on the PCWP’s achievements.
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.
Big data workshop
Rapid developments in technology have led to the generation of vast volumes of data, which can potentially transform the way the benefit-risk of medicinal products is assessed. EMA held a workshop in November 2016 to gather information on the latest developments in big data from the perspective of all stakeholders. This helps EMA and the European medicines regulatory network to identity how and when the multitude of data sources may contribute to medicine development, authorisation and post-marketing surveillance.
Adaptive pathways workshop
In collaboration with the European Commission, EMA held a workshop on adaptive pathways to gather the views and proposals from stakeholders on the adaptive pathways approach, following the publication of the final report on the pilot project. 18 representatives of patient, consumer and healthcare professional organisations participated in the workshop, which included a session on patients’ needs. A summary report of the meeting is available.
News for patients and carers
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017
Six medicines recommended for approval, including one orphan ... Read more
Orphan medicine Natpar recommended by CHMP for conditional marketing authorisation ... Read more
SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information
Diabetes patients reminded of importance of preventative foot care. ... Read more
Comments from stakeholders invited until 18 May 2017 ... Read more
Doctors prescribing Uptravi are advised to adhere to current prescribing information ... Read more
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Events of interest
The European Medicines Agency held this workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. Adaptive pathways is a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs. EMA will publish the presentations, video recording and a workshop report on this page. ... Read more
This information day will provide an update of the key elements related to the signal detection and management activities in the EU essential to the overall surveillance and risk management process of a medicinal product. We will explore the final guidance provided upon finalisation the good vigilance practice Module IX on Signal Management where the different aspects of the EU pharmacovigilance legislation on the topic will be covered. We will also drill down to the EudraVigilance access by marketing authorisation holders and the tools and training provided by the EMA to support the stakeholders. The approaches and perspectives from the different stakeholders involved in the signal management process will be also explored and discussed. ... Read more
29/03/2017 - 30/03/2017
Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop
Three projects, Asterix, IDeAl and InSPiRe, are funded by the EU 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, and are ready to discuss their results to date. The aim of the workshop 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 personalized 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
30/01/2017 - 31/01/2017
Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations)
The aim of the European Medicines Agency / ACCELERATE platform's workshop is to review unmet therapeutic needs of children with certain types of cancer and opportunities for targeted paediatric development of innovative anti-cancer medicines. The workshop brings together stakeholders from patient organisations, academia, pharmaceutical industry and regulators. The types of cancers that discussed during the workshop include soft tissue and lymphoid and embryonal neoplasms such as inflammatory myofibroblastic tumour, rhabdomyosarcoma, anaplastic large cell lymphoma and neuroblastoma. Important biological aberrations such as of the anaplastic lymphoma kinase (ALK) occur across these diverse cancers, albeit in small numbers of patients, and represent challenges to address the therapeutic needs of affect paediatric patients. ... Read more
14/11/2016 - 15/11/2016
Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science
Rapid developments in technology have led to the generation of vast volumes of data, which have the capability to transform the way the benefit-risk of medicinal products is assessed over their entire life cycle. However, it is recognised there are multiple challenges in the exploitation of these data. These range from the fundamental need to establish methods to enable the access to, integration and analysis of heterogeneous datasets to understanding the limitations in its use. Importantly, robust and transparent mechanisms to protect patient confidentiality are key to secure patient trust. It is important for the European Medicines Agency and the European Union medicines regulatory network to gather information on the latest developments in big data from the perspective of all stakeholders in order to identity how and when the multitude of data sources may contribute to medicinal product development, authorisation and post-marketing surveillance. ... Read more
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