Post-Approval Change Management On A Global Scale: An Inconvenient Complexity For Pharma?
This article was originally published in SRA
Executive Summary
Managing the post-approval regulatory change process for pharmaceuticals at the global level is complex, unpredictable and time consuming because of regional differences and frequent changes in procedures, requirements and timelines. More international harmonization of legislation relating to post-approval changes would help to increase regulatory compliance and to support continuous improvement and optimization of manufacturing and control processes, say Julia Radzihovsky, Claus-Dieter Schiller, Ralf Gleixner and Barbara Jentges.