EMA publishes human medicines highlights for 2016

The European Medicines Agency (EMA) has published a summary of its key recommendations for marketing authorisations of new medicines and the safety monitoring of approved medicines in 2016.

Key highlights are:

  • 81 medicines recommended for approval. These ‘approvals’ included 27 new active substances.
  • Of the 81 medicines recommended for approval, 17 had orphan designation. The orphan regulation was introduced to support the development of medicines for patients with rare diseases.
  • 7 medicines were recommended for approval following an accelerated assessment. This more rapid assessment timeframe (150 days versus 210 days) is awarded to medicines that are likely to address an unmet medicinal need.
  • 8 medicines were recommended for conditional approval. This is a means to allow early approval and hence early access to new medicines.
    There were 2 negative opinions and 16 withdrawn applications.
  • 59 medicines had extensions of their indications recommended for approval.


Please click here to access the summary.