EMA recommends 93 medicines for approval - 39 new active substances – in 2015

The European Medicines Agency has released an overview of its 2015 key recommendations in relation to the marketing authorizations of new medicines and the safety monitoring of authorized medicines.

2015 was an important year for public health in the European Union, it said. Therapeutic innovations that have the potential to make a difference to people’s lives were seen in particular for the treatment of certain cancers, cardiovascular diseases, and in the areas of haematology (diseases of the blood) and neurology (disorders of the nervous system).

In 2015, EMA recommended 93 medicines for marketing authorization. This includes recommendations for 39 new active substances. The US Food and Drug Administration recently released its annual tally of drug approvals (The Pharma Letter January 5), which came to 45 for 2015. However, this is not strictly comparable because the US number is for new molecules that have actually been approved, while the EMA’s total of 93 includes generics, and only lists recommendations for approval. The comparison with the 39 active substance is likely more applicable