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EMA monitors the coronavirus impact on the supply chain

The increasing prevalence of the coronavirus has led regulatory agencies including the US Food and Drug Administration (FDA) to monitor the supply chain​ for drug shortages that may occur, with the US agency having already identified the first such shortage​.

Disruptions to the supply chain was foreseen by industry experts​, however, serious concerns were raised particularly after India, one of the main providers of active pharmaceutical ingredients (APIs) globally, set 26 APIs under export restrictions​.

In an announcement on Tuesday, the European Medicines Agency (EMA) stated that it is ‘closely monitoring’ the situation, adding that, at this point, no reports of shortages or disruptions due to the outbreak have been received.

However, the agency stated that, as the public health emergency develops, shortages or disruptions ‘cannot be excluded’.

Dedicated body

To better respond to the situation, the EMA has formed the ‘EU Executive Steering Group on shortages of medicines caused by major events’.

The group is chaired by the European Commission and includes representatives of the European Commission, the Heads of Medicines Agencies (HMA), the EMA, the chairs of the Coordination groups for Mutual-recognition and Decentralised Procedures for both human and veterinary medicines (CMDh and CMDv), as well as risk communication specialists.

The group is planned to identify measures aimed at addressing the impact of the coronavirus outbreak on the European Union (EU) drug supply chain, and to coordinate actions in cases of ‘major events’, such as this outbreak.

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