EMA and European medicines regulatory network lift COVID-19 business continuity status

EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully handling the unprecedented operational challenges posed by the pandemic. This was foreseen in EMA’s workplan for 2023-2025 .

‘Throughout the pandemic we proved time and again that public health was our priority and ensured that patients in Europe could continue to have access to the newest, highest-quality therapeutics and vaccines,’ said Emer Cooke, EMA’s Executive Director. ‘Now that the peak of the pandemic has passed, the time is right for EMA and the network to close our business continuity measures. Our approach during the pandemic ensured that we could accelerate the assessment of therapeutics and vaccines for COVID-19 in an unprecedented manner while keeping assessment times for non-COVID products on schedule.’

EMA's business continuity plan was introduced in 2020 to ring-fence resources to deal with COVID-19 while safeguarding the continuity of the Agency's core activities related to the evaluation and supervision of medicines during the pandemic. It was originally put in place to prepare for the relocation of EMA from the United Kingdom to the Netherlands and operational changes linked to Brexit.

The business continuity plan for the European medicines regulatory network is also being lifted. This plan set out the principles to ensure that EMA, the European Union (EU) Member States and the European Commission could continue to operate their core regulatory activities while prioritising the assessment of COVID-19 treatments and vaccines to protect public and animal health in the EU during the pandemic.

EMA is gradually reinitiating activities that were suspended or reduced, including the planned restart of clinical data publication for all new active substances later this year. EMA’s workplan for 2023 to 2025 outlines the focus of the Agency’s work over the next two years.

Since the initiation of its business continuity plan in 2020, EMA’s mandate has been extended to include the work of its Emergency Task Force (ETF), engagement with national competent authorities and stakeholders in tackling medicines shortages, as well as new tasks in the field of medical devices. This is a direct recognition of the activities undertaken by the Agency on its own initiative during the pandemic to address pressing public health needs. The resource needs for these additional activities are covered as part of the extended mandate and lifting of the business continuity plan will not affect these areas.

While the temporary measures that were introduced to cope with the peak impact of the COVID-19 pandemic are no longer required, resourcing within the entire European medicines regulatory network remains a challenge. EMA will continue to work closely with the Heads of Medicines Agencies from the Member States to identify and implement sustainable solutions. Experiences gathered during application of the EMA and network business continuity plans, as well as lessons learnt during the pandemic, will inform this work.

The lifting of the COVID-19 business continuity measures is timely in view of World Health Organization (WHO)'s recent announcement on the end of the Public Health Emergency of International Concern (PHEIC) status of COVID-19.