EMA has published an overview of its PDF iconkey recommendations of 2018 on the authorisation and safety monitoring of medicines for human use.
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 …
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