Mitchell Parrish, JD, RAC, CIP, VP of Legal and Regulatory Affairs
ICH GCP’s new Addendum largely flew under the radar since its release coincided with the 58th presidential election. No matter the administration or any nationalist sentiment, the world is a global market with significant success achieved through cooperation. ICH GCP is a prime example of this cooperation and has helped foster the development of beneficial drugs in the U.S., Europe Union, Japan, and elsewhere. It is easy to overlook the new Addendum, given the two behemoths impacting clinical trials in the U.S.: the 21st Century Cures Act and the new Common Rule.
However, for a significant portion of those conducting drug research in the U.S., and to IRBs reviewing that research, compliance with the new Addendum is a reality not to be overlooked.