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In April, China’s State Council strengthened its regulations on vaccine distribution, in the wake of findings of suspect and poor quality vaccines at hospitals and clinics in various provinces. In June, CFDA followed up with guidance on implementing the revised regs. Along with the need for supply chain members to improve their recordkeeping practices to allow more thorough traceability and more oversight by CFDA at each stage of distribution, the guidance stresses the need for adequate storage and handling conditions, such as temperature and humidity. In its investigation, CFDA had found that vaccines that were legally produced were often kept without proper refrigeration.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
