China: First vaccine law aims to restore public confidence


China: First vaccine law aims to restore public confidence

(Source: Bio Century 2019-07-04)

With its first vaccine management law taking effect December 1, China plans to increase supervision of the vaccine life cycle and will impose penalties for fake or substandard vaccines, a move intended to restore public confidence in the wake of last year's vaccine scandal.

The National People's Congress (NPC) passed the law on June 29.

Chinese President Xi Jinping called for improvements to the vaccine management system in July 2018 after the National Medical Products Administration (NMPA) found that the Changchun subsidiary of Changsheng Bio-Technology Co. Ltd. violated manufacturing quality controls and falsified production records for freeze-dried human rabies vaccines, and that the company's diphtheria, tetanus and acellular pertussis combined vaccine failed to meet standards for biological potency.

The scandal resulted in the resignation of several drug supervision officials, including party secretary of the State Administration of Market Supervision Jingquan Bi. From 2015 to 2018, Bi was director of the CFDA, a precursor to the NMPA, where he had spearheaded reforms supporting innovation such as accelerating drug and device approvals and implementing a marketing authorization holder system.

According to the new law, clinical trials of vaccines will be conducted in top-tier hospitals or disease prevention and control institutions at or above the province level. NMPA will give priority review and approval to urgently needed and innovative vaccines.

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