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.
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 published by disease area during the previous month by the European Medicines Agency (EMA).
Patients at the heart of future innovation
On 18 March 2015 EMA marked its 20th anniversary with a scientific conference entitled 'Science, Medicines, Health: Patients at the heart of future innovation'.
Yann Le Cam (Chief Executive Officer, EURORDIS) was invited to represent the patients’ perspective on a panel discussion. Watch the video recording.
Preventing medication errors for high-strength/fixed-combination insulins
The Pharmacovigilance Risk Assessment Committee (PRAC) raised concerns about a potential risk of medication errors following recent approval of high-strength insulins (higher than the EU-wide standard 100 units/ml concentration). The PRAC developed guidance that provides a strategy to proactively address this risk in a harmonised way across the EU. Patients were extensively consulted for input based on their practical experience. The draft guidance has been released for public consultation.
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, there will be a logo to identify authorised online pharmacies and approved retailers providing authentic, authorised medicines. Read more about falsified medicines.
News for patients and carers
Ten new medicines, including two enzyme replacement therapies for rare diseases, recommended for approval ... Read more
Kanuma is first treatment for rare life-threatening genetic disease causing multiple organ damage ... Read more
Farydak shown to slow progression of rare blood cancer ... Read more
- See all News for patients and carers
Events of interest
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
European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting
This is a meeting with representatives of the Patients' and Consumers' Organisations Working Party (PCWP). Patients and consumers will share their experiences on initiatives they are involved in and will discuss PCWP involvement in preparation of guidelines on the summary of clinical trial results for laypersons. Other topics such as the involvement of patient representatives in EMA committees, and FDA engagement with patients and the activities organised to mark the PCWP’s 10th anniversary will also be discussed. Registration by invitation only. ... Read more
European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
This is a joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations. Participants will be updated on a number of topics including the European Commission study on off-label use, the EU Clinical Trial Portal and Database and the EU Network Strategy to 2020. Registration by invitation only. ... Read more
01/07/2015 - 02/07/2015
Independent, disease-based registries are a potential source of valuable safety and efficacy data on products. The European Medicines Agency (EMA) is currently embarking on a strategy for patient registries. This initiative provides an appropriate starting point to consider what regulators need from haemophilia registries. The aim is to get the best capture of data in the European Union (EU) and build on existing expertise in this area. It is proposed to work with stakeholders on this topic, commencing with this EMA workshop. Places limited. Registration open until 01/06/2015. ... Read more
- See all Events of interest