The FDA recently announced that the
Agency hopes to sign an agreement with
the European Union soon on the Mutual
Reliance Initiative (MRI). At this time,
the two entities are completing assessments
of drug manufacturing inspectorates
for two to four EU countries. The
Agency launched this initiative with the
EU in 2014 to create an expanded inspectorate
that enables FDA investigators
and trusted EU partners to work together to avoid duplicate inspections by relying
on each region’s inspection information.
This would allow the United States and
European Union to devote more resources
to regions where drug manufacturing has
greatly increased, such as China and India.