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
Six medicines recommended for approval, including three orphans ... Read more
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Medicines where suitable alternative data are available can remain on market ... Read more
EU vaccine composition advice is based on WHO recommendations ... Read more
Task force to establish roadmap and recommendations for use of big data in assessment of medicines ... Read more
EMA to set up technical group in the context of the publication of clinical data ... Read more
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Events of interest
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 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
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
Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines
The joint PCWP/HCPWP workshop on personalised medicines aims to create awareness among patient, consumer and healthcare professional organisations of how the work of the European Medicines Agency (EMA) relates to this topic. The working parties will also reflect on priority areas for future contributions in broader multi-stakeholder discussions. The objectives of the workshop include understanding how European and global landscapes are shaping policy developments, illustrating how activities of the European medicines regulatory network contribute to personalised medicine with existing legislation and regulatory tools, discussing how clinical practice and public participation can support personalised medicine in the context of European Union (EU) regulatory activities and identifying areas requiring attention from EU regulators, patients, healthcare professionals and civil society at large. EMA will publish the presentations, video recording and a workshop report. ... Read more
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