Jinan Youlyy Industrial Co., Ltd.

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- Sep 23, 2018 -

"Regulatory oversight of vaccines is critically important. It is the government's primary method of ensuring that the vaccines produced and used in China are safe, of good quality and effective," said Gauden Galea, WHO Representative for China. "This incident shows that when regulatory oversight works well, potential risks can be averted."

Good manufacturing and regulatory practices are designed to prevent problems in the process of ensuring quality vaccines. But when problems are found, the regulator must take action. WHO commends the quick and transparent actions taken by China's NDA to suspend production at the company and investigate these incidents.

WHO assessed the national regulatory authorities in 2010 and 2014, and found that they met WHO criteria as a functional regulator for vaccines with a clear commitment to continual improvement. WHO welcomes the fact that China's NDA continues to work with WHO's Regulatory Systems Strengthening program, as it has been doing for nearly 20 years. While the current incident is clearly regrettable, the detection of this event by an unannounced inspection shows that the regulatory authority's system of checks and balances to protect population health is working.