As EMA shifts to virtual meetings, agency doesn’t expect impact on drug assessments, safety monitoring
BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.
EMA says its assessment and monitoring of medicines hasn’t been affected by the COVID-19 pandemic, even as the agency transitions to virtual meetings.
The agency said Wednesday that all meetings of committees, working parties and stakeholder events hosted at its Amsterdam campus through the end of April will either be conducted virtually or postponed to later this year.
The decision affects 20 events, including two CHMP meetings and two meetings of the Committee for Advanced Therapies (CAT) which will be held virtually. Three workshops or stakeholder events have already been postponed to later this year.
While EMA said the changes won’t impact EMA’s core activities around the assessment of new medicines and pharmacovigilance of marketed products, the agency did acknowledge that the pandemic has led to the postponement of an undisclosed number of regulatory inspections.
“We are aware that some inspections have been postponed,” EMA spokesperson Sophie Labbe told BioCentury. “For any impacted sites, including those in third countries, EMA is monitoring the situation and travel restrictions in the concerned countries; decisions regarding inspections such as postponement are taken on a case-by-case basis.”
EMA is responsible for coordinating inspections of manufacturing sites, which are carried out by national health authorities in EU member states.
On Tuesday, EMA and the European Commission announced the first meeting of an executive steering group, which also includes national health authorities, to discuss measures aimed at addressing any impact the COVID-19 outbreak might have on medicines shortages.
Separately, the U.K.’s MHRA said Thursday that the COVID-19 outbreak will result in an increase in clinical trial protocol deviations as trial participants are unable to go to hospitals or complete trial activities. But the agency said that as long as trial sponsors document the deviations, it won’t be considered by regulators to be a serious breach of protocol.