EMA has published an overview of its key recommendations of 2018 on the authorisation and safety monitoring of medicines for human use.
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New medicines are essential for public health as they can improve the treatment of diseases. In 2018, EMA recommended 84 medicines for marketing authorisation. Of these, 42 had a new active substance which has never been authorised in the 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.
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 2018, 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. An overview of some of the most notable recommendations is also included in the document.
