context: Five months after being named the new State Administration for Market Regulation Party secretary and vice director, Bi Jingquan has resigned. Held accountable for the vaccine scandal in Jilin, Bi had a reputation as the most qualified and reform-minded drug regulator in two decades.
Although Bi Jingquan 毕井泉 former State Administration for Market Regulation Party secretary and vice director was in charge of drug regulation and led the inspection group that examined the vaccine scandal, his resignation alone won't solve anything; the real problems behind vaccine regulation started with institutional reforms in 2008, argues Caixin. In 2008, local governments were provided supervising powers over manufacturers in an effort to deregulate the market, but local officials lacked experience and the required expertise to oversee manufacturing and safety matters.
Bi conducted crucial reforms as State Food and Drug Administration director from 2015 to 2018, including
- streamlining drug and medical device approval processes
- pushing evaluations of generic drugs to ensure quality and develop the industry
- approving overseas clinical data in China and accelerating the process for imported drugs and innovative medical devices
Bi's resignation brings uncertainty and may result in backsliding because current stakeholders may use it as an opportunity to resist further reforms, says Caixin.