As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE is the neutral organization through which industry and global health organizations collaborate to improve product quality and patient health.
When ISPE plans to comment on a new or revised regulation or guidance, invitations to submit comments are sent to Members of relevant COPs and posted below. Prior to submission, the comments are vetted by industry SMEs and/or the Regulatory and Compliance Committee (RCC), and ISPE Regulatory Advisors.
There currently are no documents under review for comment.