FDA and EMA provide timeline updates on action against coronavirus

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Both the US FDA and EMA are updating timelines of steps taken to prevent the spread of the virus and to secure supply chains.

The US Food and Drug Administration (FDA)’s timeline is available here and the European Medicines Agency (EMA) is located here.

Both timelines provide a running update on the action each agency is taking to minimize the impact of the coronavirus on the industry’s, and their own, operations.

Today, the EMA used the feed to update stakeholders that it would participate as an observer in the European Commission’s advisory panel on the virus outbreak.

The advisory panel will convene to construct guidelines for the European Union (EU) on how to enact risk-management measures in a science-based manner.

Yesterday, the European agency noted that its own staff members will work from home until the end of April.

For its part, the majority of the FDA’s recent announcements have been regarding expediting the use of diagnostic kits, as testing in the US escalates.

Impact of medicine supply chain

The EMA has so far stated that there is no impact on medicine availability as a result of the virus. In its updated timeline, the agency maintains the same message that there are no reports of supply disruption – though it noted that “supply disruptions or medicine shortages could potentially occur as a result of a temporary lockdown of manufacturing sites.”

The agency added that it has started a review of manufacturing information to identify the products potentially ‘most at risk’. It noted that disruptions are likeliest to occur when manufacturing facilities are located in locked down areas affected by the coronavirus or if travel restrictions limit exports.

At the end of February, the FDA announced that the first shortage due to the virus had struck the US – though it did not name the product and qualified the news by stating that there were alternatives available.