A major topic in this report is the fight against the COVID-19 pandemic. This particular situation required rapid action on drug development, approval and monitoring, especially for COVID-19 vaccines and therapies. Emer Cooke, who has led the EMA as executive director since November 2020, emphasizes that this has never compromised the high standards of safety, quality, and efficacy. To that end, among other things, the EMA pandemic Task Force (COVID-ETF) and ongoing reviews were established to enable rapid decision-making and expedite approval of needed medicines. Furthermore, measures to mitigate or prevent drug shortages have been decided and implemented. In addition, due to the pandemic, there has been a decline in EMA GMP inspections, with only one-third as many conducted in 2020 as in 2019. In 2020, the EU/EEA authorities issued a total of 1843 GMP certificates to manufacturing sites around the world and only one GMP Non-Compliance Statement (for an EU site!).
Other EMA milestones in 2020 were:
EMA: Annual Report 2020
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