EMA Regulatory System Falling Behind on Innovative Cancer Drugs, Study Says

Innovative cancer drugs are taking longer to get from clinical trials to EMA approval and availability for UK patients than more conventional treatments, the London-based Institute of Cancer Research (ICR) reported.

ICR’s Chief Executive Paul Workman said Europe needs to do more to incentivize innovation, calling the drug discovery and development system “too risk averse.”

ICR looked at all drugs licensed through the EMA from 2000 until the end of 2016, categorizing them as high, medium or low innovation, with the highest level of novelty involving a new target or mechanism of action or new class of treatment in an area of unmet need.

The more innovative the drug, the longer it took to progress through clinical trials, the licensing process and review by the National Institute for Health and Clinical Excellence (NICE) for coverage through the National Health Service (NHS), the study found.