EMA: No Coronavirus-related Shortages yet, Shortage Steering Group Formed
The European Medicines Agency (EMA) on Tuesday said there are no reports of drug shortages or supply disruptions for products marketed within the EU as a result of the novel coronavirus outbreak (COVID-19), though the agency said that future shortages or disruptions “cannot be excluded.”The outbreak has sparked fears of drug shortages due to supply chain disruptions in China and abroad.
Much of the world’s supply of active pharmaceutical ingredients (API) is made in China, where factory output ground to a halt for weeks as a result of the outbreak, and India, the world’s largest exporter of generic drugs has moved to restrict exports of certain drugs and APIs to ensure local availability.
Late last month, the US Food and Drug Administration (FDA) acknowledged the first US drug shortage related to the virus.
EMA says it is continuing to monitor the situation and announced the first meeting of an EU executive steering group on drug shortages “caused by major events” to address the impact of potential supply disruptions caused by COVID-19.
The group will be chaired by the European Commission and include representatives from EMA, the Heads of Medicines Agencies (HMA) and the chairs of the Coordination groups for mutual-recognition and decentralised procedures for human and veterinary medicines (CMDh and CMDv).
EMA emphasized pharmaceutical companies’ responsibilities to ensure the supply of their products and to report any potential shortages. “This includes for instance that manufacturers put in place appropriate resilience measures such as the increase of stocks or dual sourcing of products and materials,” EMA writes.
The agency says is has also begin reviewing manufacturing information for all centrally authorized medicines “to identify those at risk of shortages and disruptions and prioritise them for discussions about remedial actions with the marketing authorisation holder.”
EMA