Biotechs Complain About International Post-Approval Change Complexity
This article was originally published in The Gold Sheet
Executive Summary
Biopharmaceutical manufacturers say that disparate post-approval requirements and review times are making it increasingly difficult to make necessary changes to their products and that the problem is getting worse. One vaccine manufacturer called the current situation “unsustainable” and others say that it is wreaking havoc on their efforts to manage products when changes have been approved in some markets but not others.