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11 March 2020Big PharmaSarah Morgan

No coronavirus-related drug shortages yet, says EMA

The European Medicines Agency (EMA) has said that no drug shortages or supply disruptions due to the coronavirus outbreak have been reported, but that a steering group has convened to address the epidemic’s impact on the supply of medicines in the EU.

Yesterday, March 10, the EMA, which is responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines, said it was closely monitoring the situation.

“As the public health emergency develops, shortages or disruptions cannot be excluded,” the EMA said in a statement.

The EMA, European Commission and national competent authorities in the member states have organised the first meeting of the steering group on shortages of medicines caused by major events.

It added: “The mandate of this group is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events, such as the COVID-19 outbreak, risks impacting the supply of medicinal products for human and veterinary use.”

In the context of COVID-19, the steering group will identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, such as where there is a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment.

“While the purpose of the group is to address disruptions of the supply of medicines in the EU through a coordinated approach, it is important to highlight that it is the responsibility of pharmaceutical companies to ensure the continuity of supply of their medicines,” the EMA said.

Shortage in the US

Meanwhile, in the US, the US Food and Drug Administration (FDA) has revealed a COVID-19-related shortage of a drug.

Stephen Hahn, commissioner of the FDA, said that a manufacturer had informed the agency of a shortage of a human drug, related to a site affected by coronavirus.

Hahn added that the shortage is due to an issue with the manufacturing of active pharmaceutical ingredients (APIs), but said that it’s “important to note that there are other alternatives that can be used by patients.”

A 2019 FDA report estimated that just over 14% of facilities making APIs for the US market were located in China. The EU and India were at 31% each.

Sister publication WIPR is running a live blog where you can find all the latest news on what COVID-19 means for IP.

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