US, EU Complete MRA on Drug Manufacturer Inspections

The European Union is hailing the completion of a mutual recognition agreement -- in the works for five years -- that the Food and Drug Administration can rely on European inspections of their drugmakers, and vice versa. The July 11 press release framed it as one of the significant goals sought by EU President Jean-Paul Juncker and President Donald Trump when they declared in July 2018 an intention to work toward trade talks and regulatory harmonization.

Slovakia was the last country to be cleared by the FDA as having high-standard inspections. As a result of this agreement, European authorities and the FDA will be able to stop spending money on inspections in the U.S. and Europe, respectively, and spend on inspections in other producing countries, like China and India.