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Human medicines
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CHAPTER 2 - DATA HIGHLIGHTS

Human medicines

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EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In 2020, EMA recommended 97 medicines for marketing authorisation. The Agency recommended one vaccine and one treatment for COVID-19, and adopted a positive opinion for a medicine for use in countries outside the EU. EMA continued to closely monitor the safety of medicines on the market and take action when needed. The product information for 490 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 2020. For more detailed information, download the full annual report 2020 (PDF version).

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SUPPORTING RESEARCH AND DEVELOPMENT

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644 Scientific advice requests received
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60 PRIME recommendations adopted and 69 eligibility request received
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RECOMMENDATIONS FOR MARKETING AUTHORISATION

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116 Applications for initial evaluation received
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97 positive opinions, 16 withdrawn applications, 2 negative opinions
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SAFETY MONITORING OF MEDICINES

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More than 1.8 million adverse drug reactions reported to EudraVigilance. 490 medicines updated, 774 periodic safety reviews recommendations.
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1888 potential signals reviewed by EMA