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CFDA to come under national market supervision administration Posted 20/04/2018

A sweeping government restructuring plan was approved by China’s National People’s Congress on 17 March 2018. The reorganization will see China’s drug regulator, the China Food and Drug Administration (CFDA), merged into an overarching market supervision administration.

The State Market Regulatory Administration (SMRA) will merge and undertake the responsibilities previously held by the State Administration for Industry and Commerce (SAIC), General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the Certification and Accreditation Administration (CAC), the Standardization Administration of China (SAC) and CFDA.

The changes mean that after five years of directly reporting to China’s State Council, CFDA will no longer be a stand-alone agency. In fact, the agency will cease to exist, with a new State Drug Administration (SDA) being established for the regulation of the life sciences and health care, under the supervision of the SMRA.

The authority of the new SDA will only extend to the provincial level, however, with post-approval marketing and sales monitoring being delegated to municipal and county SMRA departments. This it is hoped will prevent confusion over jurisdiction.

The reorganization plan is the latest in a series of changes over the past two decades. China’s drug regulator started out as a stand-alone agency in 1998 and added food to its name in 2003. It then went under the authority of the National Health Commission in 2008 and became its own entity again in 2013, only to once again come under a higher authority.

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Source: Emergo, Endpoints,RAPs,Ropes&Gray

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