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.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.