In Law360, Shanghai and Hong Kong Partners Address China’s New Market Regulator

Life sciences partner Katherine Wang (Shanghai) co-authored an April 12 article in Law360 examining the formation of China’s new State Market Regulatory Administration.

The SMRA will absorb and oversee responsibilities previously held by the China Food and Drug Administration, establishing a new State Drug Administration that will maintain its own branches at the provincial level, leaving post-approval enforcement to municipal and country branches. The SMRA will also oversee the responsibilities of the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine, the Certification and Accreditation Administration; and the Standardization Administration of China.

According to the authors, the new plan is considered the most comprehensive government restructuring that China has undertaken since the country implemented its 'Open Door' policy in the 1970s. A key policy objective is to enhance enforcement efficiency and consistency.

With the change, the Chinese leadership has created the SMRA as the single most powerful market regulator to address drug and food safety, protection of intellectual property and product quality issues, as well as overseeing antitrust and price supervision functions.