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
During its October meeting, the PRAC discussed three on going referrals. ... Read more
Focus on mid-year report and interactions with key stakeholders ... Read more
Deadline to submit expressions of interest to represent civil society at PRAC and CAT to European Commission extended until 18 October. ... Read more
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015
19 new medicines, of which two have been fast-tracked, receive positive opinions from the Committee ... Read more
- See all News for patients and carers
Events of interest
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
12/11/2015 - 13/11/2015
Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
The objective of the workshop is to discuss the important advances made in the field of pharmacokinetics-pharmacodynamics of antibacterial agents since the entry into force of the Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99). The workshop take place during the six-months consultation period for the new draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (EMA/CHMP/594085/2015). It is expected that the discussions will contribute to shaping the final draft guideline. The workshop is one of the key activities of the European Medicines Agency (EMA) to facilitate development of new antibiotics (including those targeting the treatment of multi-resistance bacteria) and is part of EMA's contribution to the global efforts of tackling antimicrobial resistance. Registration by invitation only. ... Read more
Second stakeholder meeting on the implementation of the European Medicines Agency's policy on publication of clinical data for human medicines
On 7 September 2015 the European Medicines Agency (EMA) organised a face-to-face meeting to follow-up the meeting which took place on 6 July. The aim of this meeting was to further consult with stakeholders on the two sets of guidance under development, on the identification and redaction of commercially confidential information in the clinical reports submitted to the EMA for publication, and on the anonymisation of the clinical reports, in the context of the policy. EMA also presented new technical guidance on the procedural aspects related to the submission of the clinical reports, for example practical matters of how material should be sent to EMA, as well as the workflow of the redaction consultation process and the overall process leading to publication. ... Read more
Accelerated development of appropriate patient therapies: a sustainable, multi-stakeholder approach from research to treatment outcomes (ADAPT SMART project) kick-off meeting
Around 100 representatives from patient organisations, health-technology-assessment bodies, regulators, payers, academia and industry are expected to attend this kick-off meeting for a 30-month project called ‘ADAPT SMART’, which stands for accelerated development of appropriate patient therapies: a sustainable, multi-stakeholder approach from research to treatment outcomes. The project aims to establish a platform for coordinating activities related to 'Medicines Adaptive Pathways to Patients' and enable stakeholder dialogue in this field. It is implemented under an Innovative Medicines Initiative joint undertaking, a public-private partnership between the European Commission and the biopharmaceutical industry. Registration by invitation only. ... Read more
- See all Events of interest