EMA official shares lessons learned from the COVID pandemic

BASEL, Switzerland – In a pandemic-like situation, the European Medicines Agency (EMA) should reserve resource-intensive activities for promising medicines and should reinforce its cooperation with partners such as the EU National Immunization Technical Advisory Groups (NITAGs). That’s according to the agency’s Melanie Carr, who spoke at DIA Europe 2023 on some of the knowledge EMA gleaned from the COVID-19 pandemic.

Carr, head of stakeholders and communications division and an EMA crisis manager, outlined agency processes that worked well, as well as those processes that should be improved upon, as well as areas for future action.

One of process that worked: For promising COVID treatments, EMA was able to provide enhanced presubmission dialogue with sponsors. EMA also was able to conduct “agile” assessments for promising treatments and ensure safety monitoring for these products.

Doing so allowed the agency to avoid “significant procedural delays” considering “major workload and resourcing challenges,” Carr said.

EMA also was able to provide public health advice addressing “pressing public needs beyond the scope of core regulatory approval,” she added. Another positive development was EMA’s “close and strengthened cooperation and coordination with member state authorities, the [European Commission], the [European Centre for Disease Prevention and Control] and international partners.” Further, EMA’s mandate was formally extended to address medicine shortages, she said.

Yet there were some areas that need improvement. One area that needs further examination is that large clinical studies should be able to provide “timely and meaningful results.” Also, another lesson is the need to reserve resource-intensive measures for the most promising medicines. Still another lesson was the need for EMA to maintain capacity reserves and have streamlined processes to deal with the increased workload, as well as the need for greater cooperation with NITAGS.

Some areas of future action include the ability for agency to improve the timely availability of post-authorization data through the DARWIN EU (Data Analysis and Real World Interrogation Network) program as well as the EU’s Vaccine Monitoring Program.

Another future action item is to improve the timely availability of early data in an emergency, and to refine the use of early rolling reviews during public health emergencies.

Another future priority is strengthening engagement with developers and owners of repurposed products and increasing transparency.

DIA Europe 2023

EMA official shares lessons learned from the COVID pandemic

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