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.

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

Featured information

  • 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.

  • 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.

  • 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

  • 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

  • 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

  • 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

  • 04/05/2018

    EMA

    Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: Identifying solutions for big data challenges

    The aim of this workshop is to inform thinking on big data and related challenges as the HMA/EMA Joint Big Data Task Force is planning to make recommendations in this field in November 2018. In 2017, the task force undertook detailed landscaping of the entire big data field (genomics through to m-health) as viewed through the lens of the regulator. It also performed online surveys of both national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This work helped develop an understanding of the challenges and the current state of expertise in the regulatory network. The taskforce now aims to move onto considering solutions. The task force was established in March 2017 to identify the emerging challenges created by the increasing availability of data and related opportunities for supporting regulatory decision-making. ... Read more

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