Drug Regulators Look for Common Course on Gene-Therapy Reviews

Europe’s medicines regulator is talking with its U.S. counterpart to harmonize the way the two agencies assess a new generation of therapies that repair genetic defects as a wave of the revolutionary treatments nears the market.

“We are absolutely keen to explore a common solution,” Guido Rasi, the executive director of the European Medicines Agency, said on the sidelines of a conference in Barcelona on April 23. “That could be mutually beneficial.”

The discussions revolve around how the European agency and the U.S. Food and Drug Administration can make the data and methods used to analyze cell and gene therapies—and ...