Healthcare Professionals

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.

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  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.
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  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.
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  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.
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  Ten-year report on implementation of the Paediatric Regulation

  In October 2017, the European Commission published a report on progress made in children s medicinesExternal link icon 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.

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  23/03/2018

  Updated measures for pregnancy prevention during retinoid use

  Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids.
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  23/03/2018

  Withdrawal of pain medicine flupirtine endorsed

  Serious liver problems continued to be reported despite previous restrictions in use.
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  19/03/2018

  Workshop on Paediatric Regulation – stakeholders to discuss how to boost development of medicines for children

  Event to be broadcast live on 20 March.
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  16/03/2018

  EMA Management Board: highlights of March 2018 meeting

  Board adopts 2017 report on veterinary medicines for minor use minor species and hears update on clinical trial portal and database.
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  09/03/2018

  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

  Immediate measures agreed for Zinbryta and Xofigo while reviews are ongoing; public hearing decided for quinolone and fluoroquinolone antibiotics.
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  09/03/2018

  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

  Immediate measures agreed for Zinbryta and Xofigo while reviews are ongoing; public hearing decided for quinolone and fluoroquinolone antibiotics.

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  Tue-Fri 05-08 Mar
  05/03/2018 - 08/03/2018 PRAC

  Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 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..
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  Wed 28 Feb
  28/02/2018 MB

  Extraordinary Management Board meeting: 28 February 2018

  This extraordinary Management Board meeting is to consider the building approval process for EMA’s premises in Amsterdam. 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..
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  Mon 12 Feb
  12/02/2018 EMA

  Submission of referentials management services (RMS) and organisations management services (OMS) change requests

  The European Medicines Agency’s (EMA) programme for substance, product, organisation and referential (SPOR) data services held a webinar with industry stakeholders to summarise the milestones and impacts on industry of the referentials management services (RMS) and organisations management services (OMS). The webinar focused on the submission of RMS and OMS change requests relating to referential and organisation data..
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  Tue-Fri 14-15 Dec
  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..

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