Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

approval delays
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With the Chinese government showing few signs of lifting stringent restrictions on international travel, the country’s drug makers are increasingly bearing the brunt of overseas approval delays due to the requirement to receive on-site facility inspections from foreign regulators including the US Food and Drug Administration.

The newest entrant to this growing list might be BeiGene, Ltd. The Beijing-based biotech is anticipating an FDA decision...

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