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Medicines
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CHAPTER 2 - KEY FIGURES IN 2019

Human medicines

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EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In 2019, EMA received a record number of requests for scientific advice. The numbers of applications for marketing authorisation were up again and EMA recommended 66 new medicines for marketing authorisation. EMA continued to closely monitor the safety of medicines on the market and take action when needed. The product information for 405 centrally authorised medicines was updated on the basis of new safety data. Here are some key figures on the authorisation and safety monitoring of medicines for human use in 2019. For more detailed information, download the full annual report 2019 (PDF version).

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SUPPORTING RESEARCH AND DEVELOPMENT

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549 scientific advice requests received
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57 PRIME recommendations adopted
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RECOMMENDATIONS FOR MARKETING AUTHORISATION

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117 applications for initial evaluation received
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66 positive opinions - 12 withdrawn applications - 4 negative opinions
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SAFETY MONITORING OF MEDICINES

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2 million adverse drug reactions reported to EudraVigilance
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1806 potential signals reviewed by EMA