International Dialogue Should Focus on Harmonizing Control Strategy Filings and CMC Change Requirements, Moheb Nasr’s Industry Experience Confirms

Moheb Nasr’s recent experience as a leader of global CMC strategy for GlaxoSmithKline (GSK) has reinforced his conviction that the international quality regulatory dialogue should focus on clarifying and harmonizing the filing expectations for the control strategy as a lynchpin in the advancement of the quality-by-design/continuous improvement paradigm.

At the Drug Information Association (DIA) annual meeting in late June in Philadelphia, the former director of FDA’s Office of New Drug Quality Assessment (ONDQA) reaffirmed the case he made while at the agency that agreement around the control strategy expectations could provide a risk- and science-based platform for a unified global application and post-approval change regulatory approach (IPQ “The News in Depth” July 18, 2011).

Nasr joined Acting ONDQA Director Christine Moore and EMA International and European Cooperation Sector Head Emer Cooke in addressing a session of the DIA meeting focused on manufacturing changes.

Drawing on his experience with GSK, with CMC policy setting at FDA and with the development and implementation of the ICH Q8-10 guidelines, Nasr explained the challenges industry and regulators face in advancing the new paradigm and where the pathway forward may lie (see box below).

What is needed, Nasr maintained, is for industry to become more transparent about its QbD knowledge base in applications so that the agency has the confidence to allow the self-regulation of manufacturing changes and the application review process can serve as a springboard rather than a roadblock for continuous improvement.

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