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.
2014 Annual Report of EMA interactions with patients, consumers, healthcare professionals and their organisations
The annual report describes these groups' involvement in EMA activities. The Agency has a strong commitment to working with these stakeholders and incorporating their valuable and unique viewpoints into the regulatory aspect of medicine development.
Search for herbal medicines
Use this tool to search information on herbal medicines. The information presented includes public-friendly summaries in question-and-answer format that complement the package leaflets. For more information, see the herbal medicinal products page.
September joint meeting with patients, consumers and healthcare professionals
EMA held a joint meeting to discuss the work programmes of the Patients' and Consumers' Working Party and the Healthcare Professionals' Working Party for 2016. Participants also discussed new and ongoing initiatives. Representatives from patients’, consumers’ and healthcare professionals’ organisations meet up to three times a year.
Workshop on risk minimisation measures
EMA held a workshop on risk minimisation measures for representatives of patients’, consumers’ and healthcare professionals’ organisations. The workshop explored the regulatory environment supporting the development of these measures as well as current practices and experiences in the implementation and evaluation of the effectiveness of additional risk minimisation measures.
Human medicines newsletter
Subscribe to our human medicines newsletter for a monthly update on key information on human medicines. Each issue has been selected based on recommendations from patients, consumers and healthcare professionals.
News for patients and carers
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015
Ten medicines, including a first-in-class orphan medicine for narcolepsy, recommended for authorisation in the EU ... Read more
Reports after HPV vaccination consistent with what would be expected in this age group ... Read more
Review concludes evidence does not support that HPV vaccines cause CRPS or POTS ... Read more
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Events of interest
19/11/2015 - 20/11/2015
This key end of year conference will provide an annual review of the activities of the European Medicines Agency (EMA) and the national agencies within the European regulatory system, providing European regulatory professionals a chance to reflect and plan for the challenges ahead. The conference will discuss major areas of medicines legislation coordinated by the EMA and provide practical advice on the work of EMA within the European regulatory network and on how national agencies contribute. It will feature a wide range of speakers and panellists from senior agency personnel to senior leadership, patient organisation representatives, industry leaders, pan-European policymakers and consultants. ... Read more
This one-day training session for representatives of patients' and consumers' organisations aims at presenting an overview of medicines evaluation with specific emphasis on where and how they can be involved. Using a hands-on interactive approach, participants will learn more about how they can contribute to scientific advice procedures, Scientific Advisory Group (SAG) meetings and in review of information for patients. Registration by invitation only. ... Read more
17/05/2016 - 18/05/2016
European Medicines Agency public workshop on extrapolation of efficacy and safety in medicine development
The European Medicines Agency (EMA) published in 2013 the concept paper on extrapolation of efficacy and safety in medicine development. Its aim is to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework shall set out a structured approach to be followed for each extrapolation exercise to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. EMA will host an open workshop on 17-18 May 2016, with a view to present the reflection paper and seek feedback from developers. Registration opens from 10 December 2015 to 31 March 2016. ... Read more
This workshop aims to help clarify the concept and demonstration of significant benefit of new orphan medicines over existing treatments; discuss existing methodologies for comparative efficacy and effectiveness and for major contribution to patient care, including patient preferences, and how these could be applied in demonstrating significant benefit at marketing authorisation; and discuss the impact of significant benefit on health-technology-assessment (HTA) evaluation, pricing decisions and patient access. The workshop is targeted at medicine developers, regulators, healthcare professionals, academia, patients, HTA bodies and healthcare payers. Registration has been closed early due to high demand, but it will be possible to follow the live broadcast. ... Read more
Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV)
As a requirement of the Paediatric Regulation, all new medicinal products developed for the treatment of HIV-1 infection in adults, must have an agreed paediatric investigation plan (PIP) in place, ensuring the necessary data are obtained to support the medicine's authorisation for use in children, when appropriate. The Paediatric Committee (PDCO) is responsible for agreeing these PIPs. The purpose of this expert meeting is to advise the EMA and the PDCO on the best development pathways for fixed-dose combinations for the treatment of children and adolescents living with HIV. Registration by invitation only. ... Read more
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