Healthcare Professionals

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On this page, you will find information on the Agency’s activities that are most relevant to healthcare professionals, including news, and events.

You can contribute to the Agency’s work by responding to public consultations

Learn more about how Healthcare Professionals are actively involved in the work of the Agency.

Featured information

  • Improving medicines' information

    EMA is gathering information on initiatives in the use of electronic formats to improve accessibility of medicines’ product information. This mapping exercise will be the basis of a multi-stakeholder workshop on the topic in the third quarter of 2018. Stakeholders should send feedback on projects they are aware of or working on by end of February 2018 using the survey or to ePI@ema.europa.eu.

  • Human medicines highlights 2017

    EMA has released an overview of its key recommendations in 2017 on the authorisation of new medicines. EMA recommended 92 medicines for marketing authorisation. This includes recommendations for 35 new active substances.

  • New orphan maintenance assessment reports

    As of 17 January 2018, the European Public Assessment Report (EPAR) for every newly-authorised medicine contains an orphan maintenance assessment report if it was granted orphan-designation during the development phase. This report reflects the Agency’s Committee for Orphan Medicinal Products (COMP) opinion on whether a medicine continues to meet the orphan designation criteria when it is authorised, and will be published for all positive and negative COMP opinions, as well as withdrawals. This determines whether it benefits from ten years market exclusivity, a key incentive to stimulate the development of medicines to treat rare diseases.

  • Ten-year report on implementation of the Paediatric Regulation

    In October 2017, the European Commission published a report on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago. The report shows an increase in medicines for children in many therapeutic areas in the last ten years, most notably in rheumatology and infectious diseases. However, it also shows that little progress has been made in diseases that only affect children or where the disease shows biological differences between adults and children, particularly rare diseases. The Commission and EMA and its Paediatric Committee will develop an action plan to improve the implementation of the Regulation.

  • public_hearing_report

    Public hearing at EMA

    Patients, carers, doctors, pharmacists and academics shared their experiences with valproate, a medicine currently prescribed for epilepsy, bipolar disorder and migraine, at EMA’s public hearing on 26 September 2017. 65 people attended including 28 patients and patient representatives, 19 healthcare professionals and academics, 11 attendees from pharmaceutical industry and 7 from media. There were 25 speaker contributions,grouped into 16 speaker slots. The European Parliament representative concluded that the hearing was a positive experience. A summary report is available.

  • biosimilars

    Biosimilar medicines

    EMA and the European Commission have published an information guide for healthcare professionals on the science and regulation underpinning the use of biosimilar medicines. EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide.

News for healthcare professionals

Events of interest

  • 14/12/2017 - 15/12/2017

    CHMP

    Workshop on site and histology - Independent indications in oncology

    Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment. ... Read more

  • 06/02/2018

    EMA

    Extraordinary Management Board meeting: 6 February 2018

    The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance. ... Read more

  • 09/02/2018

    EMA

    Chimeric antigen receptor (CAR) T-cell therapy registries workshop

    The objective of this workshops is to facilitate the long-term follow up of CAR-T cell products in a real world setting and enable the generation of meaningful efficacy and safety data using haemato-oncological registries. It will aim to agree on implementable recommendations on core data elements to collect and other matters including patient consent, governance, quality assurance and registry interoperability as well as recommendations to optimise collaboration among registry holders, marketing authorisation holders and applicants and regulators. ... Read more

  • 20/03/2018

    PDCO

    Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

    This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry. The deadline for expressions of interest is 14 February. EMA will select industry stakeholders via registered associations. The Agency will contact all selected participants on 1 March. ... Read more

  • 18/09/2017 - 19/09/2017

    HMPC

    Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017

    The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines. ... Read more

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