Pandemic Drives Rise In EMA Scientific Advice, But New EU Drug Filings Slow
The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.
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EMA’s Emer Cooke On The Future Of Rolling Reviews & The End Of Remote Meetings
Emer Cooke, executive director of the European Medicines Agency, has offered some insights into how the agency’s working may change following the COVID-19 pandemic, including the development of hybrid inspections.
Long-Awaited EU Clinical Trials Portal Meets Major Milestone
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”