Brexit, COVID-19 headline EMA’s 2020 annual report

Regulatory NewsRegulatory News | 14 June 2021 |  By 

The European Medicines Agency (EMA) started 2020 by wrapping up challenges associated with the UK’s decision to leave the EU, only to run headlong into additional challenges brought on by the COVID-19 pandemic. In the annual report that also marked the agency’s 25th anniversary, EMA outlined a year that looked different than most.
“As the scientific body in charge of the regulation of medicines, EMA had an essential part to play in ensuring treatments and vaccines would be authorized as quickly as possible to help fight this new disease, without compromising any of the EU standards for efficacy, safety and quality,” Emer Cooke, EMA Executive Director, wrote in an introduction for the report.
Despite this unusual start to 2020, Cooke, who took over the role from former EMA executive director Guido Rasi in November, said it was still a banner year for the agency. Overall, 97 human medicines were recommended for approval, “the highest number in over 10 years,” she noted. In 2020, the agency recommended one vaccine and one treatment for COVID-19. The year also saw EMA updating product information for 490 centrally authorized medicines.
“While the pandemic led us on a motivating but incredibly challenging journey, it has also been an opportunity for us to demonstrate the value to public health of decision-making that is based on science – and science only,” Cooke said.
Finalizing Brexit
The year for EMA began with the finalization of the agency’s permanent relocation from London to Amsterdam as part of Brexit. While the UK officially left the EU at the end of January 2020 and the UK could no longer appoint or have delegates participate in EMA science committee or working party meetings, the country continued to receive documentation from EMA procedures throughout 2020 as outlined in the UK-EU Withdrawal Agreement, EMA said.
EMA, the European Commission, and national competent authorities had been advising suppliers of medicine since May 2017 on how to lessen Brexit’s impact on medicine supplies in the EU, with regulatory changes planned early on to allow medicines to stay in the UK market. Marketing authorization holders (MAHs) previously located in the UK were also moved to an EU member state by November 2020. “Thanks to early planning and good anticipation of the changes needed, no medicine shortage occurred,” EMA noted in their report.
Roadmap to 2025
 EMA also highlighted its future direction in the report with their Regulatory Science Strategy to 2025. The agency’s goal is to create a “more adaptive regulatory system” for stakeholders within the next 5 to 10 years. Strategic areas that the initiative aims to improve are medicine availability and accessibility, data in medicine, emerging health threats and antimicrobial resistance, challenges with the supply chain, fostering innovation, and “sustainability of the network and operational excellence.”
The Regulatory Science Strategy to 2025 was published “in 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,” Cooke wrote. “This fed into the overarching Network Strategy to 2025, which was developed together with the Heads of Medicines Agencies (HMA), to guide the work carried out by the European medicines regulatory network in the coming years.”
“The goals, and the recommendations and actions stemming from them, aim to ensure that regulators can advance public health and that medicine regulation in the coming years is designed in a way that delivers optimal outcome for the European citizens.” EMA wrote in the report.
Downturn in GMP, GCP inspections during 2020
 Good manufacturing practice (GMP) inspections decreased in 2020 by 66% over the previous year, which EMA attributed to “travel and safety restrictions during the pandemic.” Of the 170 GMP inspections conducted in 2020 by European Economic Area (EEA) authorities, only one EEA inspection in the EU resulted in a non-compliance statement, EMA said.
There was also a significant decrease in the number of good clinical practice (GCP) inspections, with 59 inspections in 2020 compared to 137 inspections in 2019. Most GCP inspections were conducted in EU/EEA/ European Free Trade Association (EFTA) states. EMA’s Committee for Medicinal Products for Human Use (​CHMP) adopted just one negative opinion and centralized marketing authorizations were withdrawn in three cases due to GCP non-compliance.
EMA annual report 2020
Annexes to the annual report of the European Medicines Agency 2020


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Tags: Brexit, coronavirus, EMA, EU, UK

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