Despite a turbulent 2020, the EMA recommended the highest number of drug approvals in over a decade.
Defining 2020 for the European medicines regulator was not only the COVID-19 pandemic that forced it to fully shift its operations to working remotely shortly after it relocated to its new headquarters in Amsterdam, it was also the year it celebrated its 25th anniversary and the same year Brexit finally became a reality. During the year, it also managed to publish its Regulatory Science Strategy to 2025, which is a response “to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines”, according Emer Cooke, who took over as the Agency’s Executive Director in November last year.
In response to the emerging public health crisis, the Agency swiftly moved to also introduce rolling reviews to help accelerate assessments of COVID-19 vaccines and treatments. These allow for the Agency to review trial data from ongoing studies as it becomes available. The first COVID-19 vaccine candidate that benefitted from rolling reviews was the vaccine developed by AstraZeneca and the University of Oxford. The vaccine was subsequently recommended for conditional marketing authorization (CMA) in late January this year. Another candidate developed by Janssen-Cilag also benefited from this. The vaccine was recommended for CMA in March. Overall, the Agency managed to recommend 97 new human medicines for approval - the highest number in more than a decade.