Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation.

High on the priority list are a common definition of what information in marketing applications is a regulatory commitment and a broader adoption of “do and tell” mechanisms for notification of minor, low-risk changes.

The regulatory quagmire global companies face in trying to make post-approval adjustments to their manufacturing and control processes received front-burner attention at the CASSS/FDA WCBP Symposium in late January in Washington, D.C.

A plenary session was held at the conclusion of the conference to focus specifically on the post-approval change problem and pathways to address it. Highlighted were the amount of valuable resources that the problem consumes, the extended and varying clearance timelines, and the product distribution complexities that ensue.

The result, the participants noted, is that manufacturing and control improvements are not being made that should be and the supply of products to patients is being jeopardized.

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