China’s drug agency under scrutiny

Low-quality drugs have flooded the Chinese market Copyright: Newsphoto

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The recent scandal at China’s State Food and Drug Administration (SFDA), which led to the execution of its former head (see China’s former drug boss faces death sentence), resulted in criticism from both top Chinese officials and the public.

But China’s political and economic environment is also partly to blame, writes Jia Hepeng in this Nature Biotechnology article.

In 1998, the government established the SFDA in an attempt to strengthen the country’s drug regulations. The agency rapidly set up mechanisms to ensure adherence to drug standards, including enforcing good manufacturing practice and centralising drug approvals.


But these measures, say critics, also led to the excessive increase in size of pharmaceutical firms, official corruption and low-quality drugs.

The SFDA has also been criticised for approving too many new drugs based on much looser criteria than that used in Europe and the United States.

But disciplining SFDA officials won’t encourage innovation, writes Jia. The industry needs more scientific regulation and a healthier political environment in which to function.

In a separate Nature article, Jane Qiu reports on the SFDA’s new drug approval rules, which aim to ensure that no single person or department is responsible for the drug approval process (see China drugs agency must play by new rules). Spot checks on drug companies and even long-term surveillance will become common.

But while the measures are seen as a step in the right direction, sceptics argue that a truly independent watchdog, full transparency, a culture of accountability and a mature legal system are what China needs to combat corruption — and these can only come with time.

Link to full article in Nature Biotechnology


Link to full article in Nature