EMA: Human medicines: highlights of 2015
93 medicines recommended for approval – 39 new active substances
The European Medicines Agency (EMA) has released an overview of its 2015 key recommendations in relation to the marketing authorisations of new medicines and the safety monitoring of authorised medicines.
2015 was an important year for public health in the European Union (EU). 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 authorisation. This includes recommendations for 39 new active substances.
Monitoring in real life – optimising safe and effective use
Once a medicine is available to patients, EMA and the national competent authorities of the EU continuously monitor the benefits and risks that patients experience with the medicine in real life.
In 2015, EMA gave new safety advice to manage risks observed with a number of medicines on the market in the EU. The product information of these medicines was updated to provide the best information possible to patients and healthcare professionals to enable informed decisions when using or prescribing a medicine.
A selection of these recommendations can be found in the document published today.
Posted on the EMA website on 12 January 2016