3 CFDA national leaders and 7 provincial leaders have been demoted as a result of the recent vaccines poor quality incident for the oversight over the substandard vaccines manufactured by the Changchun Changsheng Bio-tech Co today, August 16.
Wu Zhen, former deputy head of CFDA, responsible for pharma & vaccine registration, regulation and quality affairs nationwide, is under investigation for suspected serious violations of Party disciplinary rules and laws.
Bi Jingquan, former head of CFDA was asked to resign from his current position as head of the ruling party and deputy director of the all-powerful State Administration for Market Regulation. The agency, to which the CFDA belongs, was created in March 2018 as part of central government restructuring. Bi’s name has already been removed from the CFDA’s website.
Jiao Hong, once a deputy director at CFDA and currently the chief of CFDA, will have to hand in a self-review to reflect on her missteps.
Chinese president, Xi Jinping, called for improving long-term oversight mechanisms for vaccine production and public safety.
Such a major group of CFDA VIPs being demoted due to the recent vaccines scandal clearly show the major weakness of post market monitoring and supervision. The vaccine scandal was the result of the manufacturer’s neglect of quality system forpublic safety. Even though the incident was not the direct doing of these CFDA VIPs and other impacted CFDA key personnel, China central government still held them accountable and levied punishment on them. In the U.S. we would expect an army of attorneys will be suing the manufacturer representing the citizen for millions of dollars. U.S. FDA will most likely not be in the forefront of the scandal. U.S. FDA chiefs and key people are not going to be demoted by the White House. This example shows the difference of post market responsibilities by the regulatory key people in the two largest medical device/IVD countries in the world – China CFDA personnel seems to bear personal responsibilities as well.
China medical device/IVD post market monitoring and supervision is still at its infancy stage relative to the maturity level of the U.S. FDA. China’s new GMP for class II medical devices was put into effect on January 1st, 2018. The GMP for class III was effective the year before. The number and experience of the post market field auditing personnel from CFDA at both provincial and national levels are limited. We expect the vaccines incident will certainly expedite the expansion of the field auditing personnel as well as raising the level of regulation requirements for post market monitoring and supervision.
For webinar on CFDA GMP requirements for medical device, please see https://chinameddevice.com/cfda-key-updates-gmp-qms-overview-video/
For slides on CFDA overseas inspection, please email info@ChinaMedDevice.com.
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China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.