China’s drug regulator clears 45 vaccine firms of safety issues

Source:Global Times Published: 2018/9/7 21:23:40

All 45 Chinese vaccine manufacturers showed no quality or safety issues during the drug regulator's recent inspection, the China Food and Drug Administration announced Friday.

The administration sent 45 inspection teams to the country's 45 vaccine producers from July 23 to August 9, excluding the Changchun Changsheng Bio-technology Company, which was found supplying ineffective diphtheria, whooping cough and tetanus (DPT) vaccines and forging data for rabies vaccines.

The inspection results showed that production was normal at all the companies, and no quality and safety issues were found.

Thirty-eight of the 45 companies established a fine quality management system, equipped with standard personnel and facilities and controlled the quality of the vaccines based on the related drug registration standard. Seven vaccine producers have suspended their production for at least three years due to failure to renew their license, poor operations and renovation of workshops, the administration said.

Inspection officers checked the facilities, production and quality management, and verified the production and data records. The administration vowed to strengthen supervision of the vaccines, and establish a traceability system to vaccine quality and safety, and intensify inspections and tracking supervision.

The Changchun Changsheng scandal has seen more than 40 officials, including seven provincial- and ministerial-level officials, held accountable in August.

Global Times

Posted in: SOCIETY

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