Pharmaceutical industry
On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events. You can contribute to the Agency’s work by responding to public consultations. Learn more about how the pharmaceutical industry is actively involved in the work of the Agency.
Featured information
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Public consultation on draft framework for paediatric clinical trial preparedness
The European Network of Paediatric Research at the European Medicines Agency invites all stakeholders involved in paediatric clinical trials to provide comments on its draft framework on paediatric clinical trial preparedness by writing to enpremasurveys@ema.europa.eu, by 15 November 2019. The aim of this consultation is to identify potential gaps and present a more comprehensive view.
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Brexit preparations
In July 2019, EMA and the European Commission provided additional information on exemptions for batch testing to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
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Early access approaches in the EU and the US
EMA has published a report on its joint stakeholder workshop with the US Food and Drug Administration (FDA) that explored how to better support medicine developers generate quality data packages in early access appraches in the EU and the US, including the PRIME scheme in the EU and the Breakthrough Therapy designation in the US.
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Supporting medicine developers
EMA's infosheet highlights the regulatory tools EMA offers to support the development of new and innovative medicines – from the early phases in the laboratory all the way to the patient.
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The journey of a centrally authorised medicine
EMA's booklet describes the journey of a medicine for human use authorised via EMA, from initial research to discussions on patient access to medicines across the EU. This includes how EMA supports medicine development by providing scientific advice and how it assesses a medicine’s benefits and risks once it receives an application for marketing authorisation.
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Names of liposomal medicines to be changed
All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to EMA or the relevant national competent authority(ies) to change the names of these medicines as soon as possible before the end of September 2019. The aim is to avoid medication errors.
Key content
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Research and development
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Innovation in medicines
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Pharmacovigilance
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Data on medicines (ISO IDMP standards)
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United Kingdom’s withdrawal from the European Union ('Brexit')
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Supporting SMEs
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PRIME: priority medicines
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Antimicrobial resistance