EMA publishes 2018 highlights report, offering regulatory insights

The European Medicines Agency (EMA) has published its annual highlights of 2018 medicines approvals.

This short summary document provides a review of the medicines considered by the EMA in the last year, and statistics on medicine types and the regulatory routes used. Some key notes are:

  • Of the medicines reviewed, 85% resulted in a recommendation
  • Of those recommended, 21% of applications were for medicines with orphan designation
  • Cancer medicines again dominated, representing 23% of approvals
  • All of the drugs recommended via special routes discussed below were not only new active substances (NAS), but also had orphan designation
  • Four recommended medicines (4%) went via EMA accelerated assessment, across varied therapy areas
  • Three recommended medicines were approved under exceptional circumstances; these were all for endocrinology
  • Three ATMPs (Advanced Therapy Medicinal Products) were approved, including two CAR-Ts for cancer indications, and one opthamology gene therapy
  • Two medicines were approved under the PRIME (PRIority Medicines) programme (the CAR-T ATMPs above)
  • A single drug was approved under a conditional marketing authorisation, and was for cancer

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Published 8. January 2019 in News, News EU