Healthcare Professionals

  • Email
  • Help

Information for you

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

  • European Immunization Week

    EMA supports European Immunization Week from 23-29 April. The Agency pulished a statement of its Executive Director, Prof. Guido Rasi and produced a video together with the patients, consumers, doctors, nurses and pharmacists it works with across the EU, who explain why vaccination matters.

  • Orphan medicines: getting the facts straight

    EMA has published a question-and-answer document addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines, including significant benefit and market exclusivity. For more information, see Orphan designation.

  • 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.

  • 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

  • 07/06/2018

    EMA

    2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

    Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research networks, learned societies, national paediatric associations/societies, ethics committees, regulators, Health Technology Assessment bodies and industry); and ii) an interactive general discussion on how to avoid duplication of trials, how to improve communication, how to divide work between groups and on the challenges of clinical trials in (ultra) rare diseases. The following day is reserved for discussions among the members of Enpr-EMA. ... Read more

  • 05/09/2018 - 06/09/2018

    PDCO

    Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients

    The third multi-stakeholder Paediatric Strategy Forum, jointly organised by EMA and ACCELERATE will focus on checkpoint inhibitors used in combination therapy, in children and adolescents. This Forum will reviewed the immunological environment of paediatric malignancies, checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest using the forms linked to this page. ... 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

  • 26/03/2018 - 27/03/2018

    HMPC

    Committee for Herbal Medicinal Products (HMPC): 26-27 March 2018

    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

  • 11/06/2018 - 14/06/2018

    PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018

    The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. ... Read more

  • See all Events of interest

Information for:

Find information for...

FAQ spotlight