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8 April 2020Big PharmaRory O'Neill

EMA unveils fast-track drug shortage monitoring

The EU’s drugs regulator has set up a fast-track system to monitor shortages during the COVID-19 pandemic.

The  European Medicines Agency (EMA) today, April 7, revealed that it would be overseeing a shortage reporting system, whereby pharmaceutical companies would report directly to the EMA anticipated or current shortages of critical drugs needed during the pandemic.

According to the EMA, it has been notified of expected shortages of medicines used in intensive care units, including anaesthetics, antibiotics, and muscle relaxants.

As recently as  March 10, the EMA said it had yet to observe any coronavirus-related drug shortages. But as the crisis intensifies across Europe, the regulator is now bracing itself for limited supplies of key medicines in EU member states.

Europe is not the only territory to be hit by COVID-19-related shortages, with the  US Food and Drug Administration last month reporting an impact on supplies.

The issues stem in part from the world’s reliance on Asia for the manufacture of active pharmaceutical ingredients (APIs), the key chemicals used in drugs.

India, one of the world’s biggest suppliers of APIs, announced an  export ban last month aimed at protecting its own supplies during the pandemic.

French drugmaker Sanofi has announced plans to create  Europe’s largest API manufacturer, in an attempt to reduce dependence on Asia.

Meanwhile, the EMA’s new reporting system is being organised under the auspices of an EU steering group established to tackle shortages last month, consisting of the EMA, the European Commission and representatives of EU member states.

European authorities are also considering shortage mitigation measures, such as expedited approval of new manufacturing sites.

“Discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of supply shortages,” the EMA statement said.

The EMA pledged to provide more clarity on regulatory changes to ease shortages in a forthcoming question-and-answer document.

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