EMA Publishes 2019 Annual Report

On June 15, 2020, the European Medicines Agency (EMA) released its annual report, which details the initiatives, accomplishments, and challenges the agency experienced in 2019. The report, which is available in a digital version, discusses the agency’s regulatory science strategy to 2025, recommendations on the use of big data, and the agency’s response to the nitrosamine impurities situation. The report also provides statistics on EMA’s regulatory procedures and activities.

One of the major tasks EMA took in 2019 was relocating from the London to Amsterdam due to the United Kingdom’s exit from the European Union. According to Executive Director, Guido Rasi, the moved caused EMA to focus on continuing the supply of medicines in the EU. “Most of the activities we had to postpone and suspend in 2018 in anticipation of the physical move remained on hold in 2019. These included guideline development, engagement in international activities, the majority of working party meetings, and the agency’s landmark policy on the proactive publication of clinical data,” Rasi said in the report’s introduction. EMA was able to continue some projects in the second half of 2019 including enhancing IT systems and digitalizing administrative processes.

The agency did lose some staff because of the move, however, and has been working to fill the empty positions. “Overall, including short-term staff who could not be transferred, we lost 159 people in 2019, which put our operations under pressure. A successful recruitment drive attracting over 5000 candidates has helped to redress some of this loss, but recruitment-and in particular finding the right expertise-will remain a focus area for the agency,” Rasi said in the report.

According to Rasi, 66 new medicines were recommended for human use by the agency in 2019, including the first Ebola vaccine. The agency also updated the authorizations for 405 medicines based on new safety data. Drug shortages were also tackled by the agency in 2019, with the creation of an information-sharing system for EU regulators.

“I approach 2020 with the hope that we can now finally close the chapter of our relocation and focus on the future. This will be my last year at the helm of EMA, an organization that has been my privilege to lead, and it is my ambition to leave it fully prepared to embrace the scientific and technological advances ahead for better human and animal health,” Rasi said in the report.

Source: EMA