The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Asked to Form a Global Perspective on CMC Controls

Feb. 26, 2016

Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes.

The draft guidance is intended to clarify regulations addressing how and when drugmakers need to report changes in their CMC processes to regulators. In October, the FDA reopened its comment period.

Many of the 22 organizations that filed statements during the extended comment period raised questions about the FDA’s effort coinciding with the International Conference on Harmonisation — which is evaluating similar issues with the development of ICH Q12 — and suggested the FDA should coordinate with ICH.

PhRMA said it supported the FDA’s intent to focus postapproval regulatory review activities on defined CMC issues, but it also emphasized the need for globally harmonized guidance.

“We believe that this complex issue would be better addressed through a globally harmonized guideline,” wrote Michael J. James, GSK’s director of CMC Advocacy & Policy Global Regulatory Affairs. Once there is successful “completion and adoption of the (ICH) Q12 guideline,” he wrote, then “the FDA would consider the finalization and implementation of this guidance.”

AstraZeneca first raised that point when the guidance was released, and Pfizer also said the guidance talks extensively about control strategy without referencing ICH Q8, 10 and 11.

Other comments pointed to the need for eliminating reporting requirements. As part of the application process, the FDA said it would assess established conditions in conjunction with the applicant’s level of understanding about product and processes, risk assessment activities and the proposed control strategy.

Pat Watson, executive director of Boehringer Ingelheim’s CMC Regulatory Affairs, said industry is most interested in receiving FDA’s thinking on how companies can establish confidence with the agency to reduce or eliminate certain reporting requirements.

He stressed that the guidance would not enable a more effective post-approval submission strategy using risk management principles.

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