Bye CFDA: China’s drug regulator to take new shape in major government restructuring

A sweeping government reorganization has rewoven the China Food and Drug Administration into the fabric of an overarching market supervision administration, giving birth to a drug regulator under its purview.

The changes mean that after five years of directly reporting to the State Council, the CFDA will no longer be a standalone agency. The newly created market supervision administration will have a broad mandate covering anti-monopoly laws, price control, consumer goods quality and safety, etc — and that includes everything food-related. It will, however, leave the matters of drug approval to a sub-administration dedicated to drug regulation.

Of note is the fact that the new drug regulator’s authority only extends to the provincial level, delegating post-approval marketing and sales monitoring to county and city market supervision departments.

Those departments already exist in a number of local governments, which consolidated commerce, quality control and food/drug departments into one big structure instead of following the example of the State Council in 2013, which created the standalone food and drug administration.

Hu Yinglian

That helps avoid confusion about overlapping authorities, while allowing the professional work of drug evaluation in professional hands, Chinese Academy of Governance professor Hu Yinglian told local magazine Caijing.

The reshuffle plan, which is widely expected to be formally endorsed by the National People’s Congress later this week, is the latest in a series of back and forth changes over the past two decades.

Starting out as a standalone drug administration in 1998, the agency added food to its name in 2003, went under the authority of the National Health Commission in 2008, only to become its own entity again in 2013 — until now.

Exactly what the new structure would look like remains unclear, but we do know one thing for sure: President Xi Jinping would likely stay in power for the rest of his life to oversee these changes, thanks to a constitutional amendment passed weeks ago.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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