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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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.
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.