Human medicines
CHAPTER 2: DATA HIGHLIGHTS

Human medicines

EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In 2021, EMA recommended 92 medicines for marketing authorisation. The Agency recommended four vaccines and five treatments for COVID-19. Throughout the year, EMA approved 33 new manufacturing sites for COVID-19 vaccines, leading to a substantial increase in vaccine manufacturing capacity and supply. EMA continued to closely monitor the safety of medicines on the market and take action when needed. The product information for 502 centrally authorised medicines was updated on the basis of new safety data in 2021. Here are some key figures on the authorisation and safety monitoring of medicines for human use in 2021. For more detailed information, download the full annual report 2021 (PDF version).

SUPPORTING RESEARCH AND DEVELOPMENT

690 scientific advice requests received
58 PRIME recommendations adopted

RECOMMENDATIONS FOR MARKETING AUTHORISATION

116 Applications for initial evaluation received
92 positive opinions, 7 withdrawn applications, 5 negative opinions

SAFETY MONITORING OF MEDICINES

More than 3.5 million adverse drug reactions reported
2477 Potential signals reviewed by EMA

For more information, please read the full PDF document.