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 2015
EMA has released an overview of its key recommendations in 2015 on the authorisation of new medicines and the safety monitoring of authorised medicines. EMA recommended 93 medicines for marketing authorisation. This includes recommendations for 39 new active substances.
EMA meeting with all eligible organisations
The Patients' and Consumers' Organisations' Working Party (PCWP) held a meeting with all eligible patient and consumer organisations at the end of 2015, to discuss patient involvement in EMA activities in 2015 as well as the work plan for 2016. The meeting also discussed the outcome of the pilot of publishing risk-management plan summaries as well as herbal monographs. The PCWP also presented patient-led training initiatives.
Significant benefit of orphan medicines
EMA held a workshop to demonstrate the significant benefit of new orphan medicines over existing treatments. The workshop also discussed existing methodologies for comparative efficacy and effectiveness and for major contribution to patient care, as well as the impact of significant benefit on health-technology-assessment evaluations, pricing decisions, and access to orphan medicines.
Prevention of medication errors
EMA has a dedicated webpage listing all additional measures it has recommended to reduce the risk of medication errors with a specific medicine. The new webpage was launched in paralell with the good practice guide on medication errors.
Training for patients and consumers involved in EMA activities
EMA provides tailored training for patients and consumers involved in activities related to medicines. An annual one-day training session offers an overview of medicines evaluation with specific emphasis on where and how to get involved. Using a hands-on interactive approach, participants learn more about how they can contribute to scientific advice procedures, Scientific Advisory Group meetings and reviewing information for patients.
News for patients and carers
PRAC concludes three safety reviews ... Read more
New advice may help early detection of PML and improve patients’ outcomes ... Read more
Committee had concerns over serious allergic reactions and limited evidence of benefit ... Read more
Healthcare professionals should be aware of possible atypical cases ... Read more
New regulation introduces ‘safety features’ on the packaging of medicines for human use ... Read more
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Events of interest
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. ... Read more
This workshop aims to help clarify the concept and demonstrate the significant benefit of new orphan medicines over existing treatments. It will 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 as well as 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. ... 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. ... 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. ... Read more
European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: workshop on risk minimisation measures
This is a workshop on risk minimisation measures with representatives from patients’, consumers’ and healthcare professionals’ organisations. An overview of the regulatory environment supporting the development of risk minimisation measures will be provided to participants; In addition, current practices/experience in the implementation and evaluation of the effectiveness of additional risk minimisation measures will be shared, using concrete examples. Participants will also discuss challenges and opportunities posed by the implementation and evaluation of risk minimisation measures in real life clinical practice. Registration by invitation only. ... Read more
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