EMA Creates New Drug Shortage Reporting System

The European Medicines Agency yesterday announced a new system for reporting drug shortages and potential supply disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines.

For the first time, companies will report directly to the EMA about current and anticipated shortages of medicines critical to efforts against the coronavirus for both nationally and EU-authorized drugs. Currently, companies only report to the regulatory authorities in their individual EU member states.

Under the EMA’s industry single point of contact system (i-SPOC), each drugmaker will have a designated point of contact who will feed information to the agency. But companies will still be expected to report shortages to their national regulators.

“This is a new type of activity that cannot make use of existing mechanisms” and means the agency is having to put in place new processes and prioritize resources, EMA said.

Drugs currently facing shortages include intensive care unit medications, such as anesthetics, antibiotics and muscle relaxants, as well as drugs being used off-label to treat COVID-19 patients. — James Miessler