The European Medicines Agency (EMA) has published its yearly overview of key recommendations for 2017, covering the authorisation of new medicines and related safety monitoring.
The overview reveals the EMA recommended 92 medicines for approval. Of these, 35 contained new active substances never before authorized in the European Union. Most of these medicines are aimed at the treatment of cancer and infections, although significant advancements have also been made in neurology, endocrinology and gastroenterology, including applications for Crohn’s disease patients.
With the publication of the 2017 highlights, Dora Wirth Languages (DWL) is proud to have worked on many of the featured medicines approved last year. Our work entailed translating the product information for each of the 24 languages of the EU/EEA member states, managing project delivery and ensuring compliance with EMA guidelines. DWL contributed to a number of new applications and extensions, as well as several variations for existing products.
Read the EMA summary in full here: