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.
Information session on biosimilars
The Agency held an information session on biosimilars aiming to provide an overview of the science behind biosimilars and how they are evaluated by regulators. The session also explored public acceptability of biosimilars and the role of communication in promoting better understanding of biosimilar medicines.
European public assessment reports (EPARs)
Use this tool to search all EPARs for human medicines published by the European Medicines Agency (EMA). The information presented includes public-friendly summaries in question-and-answer format and the package leaflets. See our page on background and context for more information on EPARs.
Newsletter - Human medicines highlights
This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use by disease area published during the previous month by EMA.
Beware of falsified medicines!
Falsified medicines are fake medicines that may enter the supply chain illegally. Be careful about the way you buy medicines. For internet sales, the European Commission has introduced a common logo that appears on the websites of authorised online retailers to reduce the risk of buying falsified medicines online.
News for patients and carers
Expressions of interest to represent civil society at PRAC and CAT to be submitted to European Commission by 30 September 2015 ... Read more
Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU ... Read more
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions ... Read more
Medicine to offer therapy for patients unable to control high cholesterol with currently available treatment ... Read more
Intuniv to be used in combination with comprehensive behavioural treatment in children and adolescents ... Read more
- See all News for patients and carers
Events of interest
European Commission conference - 50 years of European Union Pharma legislation: achievements and future perspectives
To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organising a one-day conference that will take place in Brussels on 28 September. The conference will review past achievements but also focus on the present and future role of EU pharmaceutical legislation in protecting the health of people in Europe and in the world, and in advancing science and innovation. There are still many challenges ahead. Different stakeholders view these challenges from different perspectives. The conference aims to facilitate an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups towards a shared vision for the future. Registration open until 24 July 2015. ... Read more
01/10/2015 - 02/10/2015
Annual joint European Forum for Good Clinical Practice / Drug Information Association / European Medicines Agency conference
Nearing a decade of the European Union (EU) Paediatric Regulation, with close to 2,000 submitted paediatric investigation plans, paediatric needs are recognised as an integrated part of drug development with the inclusion of children now accepted as standard procedure. However, challenges remain, which can result in delayed access by children to innovative medicines. This year’s joint Drug Information Association/ European Forum for Good Clinical Practice/ European Medicines Agency (EMA) annual paediatric conference will focus on ways to overcome these challenges, such as through collaboration, extrapolation, modelling & simulation and adaptive pathways. The conference will provide an opportunity to interact with EMA paediatric coordinators, members of the Paediatric Committee and other stakeholders interested in paediatric drug development. Patients’ and Healthcare professionals’ views will complement the reports of practical experience. ... Read more
Workshop on first-line acute promyelocytic leukaemia treatment: European Union cooperative groups and the pharmaceutical industry
The European Medicines Agency (EMA) is hosting a meeting with European clinical cooperative groups, the pharmaceutical industry and other regulators to discuss first-line treatment of acute promyelocytic leukaemia (APL). The topics addressed will include a historical outlook of APL treatment, recent published trials using arsenic trioxide, guidelines on clinical trials in small populations, experience with the assessment of marketing authorisation applications for rare cancers based on academic trials, benefits to patients of further product development and regulatory submissions. Registration by invitation only. ... Read more
Current status of European Medicines Agency policy on publication of clinical data - Stakeholder webinar
The European Medicines Agency (EMA) is organising a webinar on the implementation of its policy on publication of clinical data for medicinal products for human use, which came into effect on 1 January 2015. The aim of the webinar is to update stakeholders on the progress the Agency has made on the implemetation of the policy. The topics covered by the webinar will include an explanation of the principles for the submission of redacted clinical reports, the redaction consultation process, as well as guidance on what is and is not considered commercially confidential information and on the anonymisation and redaction of personal data in clinical reports. Registration closed. ... Read more
28/05/2015 - 29/05/2015
Annual workshop of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
Day one of the workshop, 28 May, is an open meeting to all stakeholders: patient/parent organisations, network representatives, pharmaceutical industry staff responsible for paediatric studies and regulators. Day two, 29 May, is dedicated to members of Enpr-EMA and its Coordinating Group. Registration is open until 15 May 2015 using the registration form. ... Read more
- See all Events of interest