FDA expands mutual reliance and harmonization with trusted f

FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to strengthen the resiliency of globalized drug supply chains | Hogan Lovells


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The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. Indeed, FDA was forced to accelerate its work to advance regulatory convergence with trusted foreign regulatory partners by sharing information to complete inspectional activities, to advance certain medical product applications through the review process, and to help mitigate potential drug shortages. FDA’s “Resiliency Roadmap for FDA Inspectional Oversight” issued this month, summarizes the agency’s use of alternative inspectional tools and priorities going forward, calling the work to further leverage information shared through mutual recognition agreements (MRAs) “increasingly vital.” For example, FDA assessed expanding the use of MRA beyond in-country inspections to include third-country inspections, and began to accept and classify third-country inspections.

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