92 medicines recommended for approval, including 35 with a new active substance
The European Medicines Agency (EMA) has published an overview of its key recommendations of 2017 regarding the authorisation of new medicines and the safety monitoring of medicines.
Advances in medicines authorisations are essential for public health as they have the potential to improve the treatment of diseases. In 2017, EMA recommended 92 medicines for marketing authorisation. Of these, 35 had a new active substance, which has never been authorised in the European Union (EU) before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies. An overview can be found in the document published today.
Once a medicine is placed on the market, EMA and the EU Member States continuously monitor the quality and the benefit/risk balance of the medicine under its authorised conditions of use.
In 2017, EMA gave new safety advice to manage risks observed with a number of medicines on the market in the EU. Regulatory measures ranged from a change to the product information to the suspension or withdrawal of a medicine or the recall of a limited number of batches. An overview of some of the most notable recommendations is also included in the document.