International Activities
CBER has outlined five functional areas for its international activities: regulatory harmonization, capacity building, information sharing, international standards setting, and collaborative research.
This affects stakeholders in the biologics, vaccine, and blood product sectors, specifically personnel in regulatory strategy, international clinical trial management, and quality compliance.
These activities suggest a continued commitment by CBER to align biologics regulation globally. For manufacturers, this may lead to more standardized expectations across different jurisdictions, potentially reducing friction in multi-market entries. The focus on information sharing and standards setting implies that international data and benchmarks will remain central to CBER's evaluation processes.
Regulatory teams should monitor international standards-setting bodies and harmonization efforts as they may influence CBER's future submission requirements. Quality and research departments should ensure that data generated in international collaborations align with the evolving standards described in these functional areas.
CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.
Open in openFDA / FDA.gov