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Shaping regulatory science to 2025
Shaping regulatory science to 2025
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Shaping regulatory science to 2025
Shaping regulatory science to 2025
EMA is hosting a multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ on 18-19 November. Participants will discuss the outcome of EMA’s public consultation on the draft strategy. The workshop can be followed via live broadcast.
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Guide on biosimilars for healthcare professionals available in 23 official EU languages
Guide on biosimilars for healthcare professionals available in 23 official EU languages
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Guide on biosimilars for healthcare professionals available in 23 official EU languages
Guide on biosimilars for healthcare professionals available in 23 official EU languages
The information guide on biosimilars for healthcare professionals was translated into 15 additional official EU languages: Bulgarian, Czech, Danish, Greek, Estonian, Finnish, Croatian, Hungarian, Lithuanian, Latvian, Maltese, Romanian, Slovak, Slovenian and Swedish.
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Nitrosamine impurities: latest information
Nitrosamine impurities: latest information
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Nitrosamine impurities: latest information
Nitrosamine impurities: latest information
Visit our new webpage on nitrosamine impurities in human medicines for a full, up-to-date overview of EMA’s past and ongoing reviews into this issue. It includes new templates for marketing authorisation holders to report the outcome of the requested risk evaluation and testing, as well as the updated questions-and-answers document with a list of potential sources of nitrosamine contamination. Bookmark the page for quick access to the latest updates.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information on exemptions for batch testing to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
