HONG KONG – Underscoring the speed in which China is working to raise its drug regulations to international standard, the World Health Organization (WHO) gave the country's national vaccine regulatory system a stamp of approval in a follow-up assessment since a first inspection was done in 2011.
"You have met established benchmarks that define international requirements for a functional vaccine regulatory system," said Margaret Chan, director-general of the WHO at the agency's announcement conference on the Conclusion of National Authority Reassessment on Chinese Vaccine Regulatory System held in Beijing on July 4.
The CFDA "is well on its way towards meeting the highest international standards for a regulatory authority," Chan said. "The results of the WHO assessment are good news for China, but also for the rest of the world."
Zhang Yong, minister of the CFDA, said at the announcement conference that China would fulfill its duty as a WHO member in disease prevention and control.
"The CFDA will keep working closely with the WHO and keep perfecting the national vaccine regulatory system," Zhang said. "We will have long-term and thorough communication with international organizations on new situations and problems we confront in China's vaccine industry."
He also pointed out that China had been improving the whole process of vaccine supervision and carefully implementing good manufacturing practices (GMP) so that the system was gradually evolving and the authority's risk-control capability was greatly increased.
The WHO stamp of approval of China's vaccine regulations means that domestic companies with CFDA approval can more easily supply vaccines to the domestic population and internationally. As part of the assessment, the WHO considers whether domestic regulations ensure that China-made vaccines are safe, effective and of high quality.
Building on that positive assessment, the CFDA signed a declaration of joint commitment with the WHO to enhance the CFDA's regulatory system for vaccines, other medical products and for food safety management.
For both China and the WHO, ensuring that China has the capacity to supply reliable vaccines to countries around the world is a priority.
"The demand for vaccines is increasing at a time when the number of countries producing vaccines is declining," Chan said. "China has the largest vaccine manufacturing capacity in the world.
"With the latest seal of approval from the WHO, China is in a position to make high-quality vaccine supplies more abundant, predictable and affordable. . . . It also strengthens China's long history of collaboration to improve health in Africa."
In March 2011, a WHO-led team completed a review of the regulatory process in place in China. At the time, those regulations were controlled by the State Food and Drug Administration (SFDA), a body that morphed into the CFDA last year.
Three years ago, the WHO team determined after a 19-month effort that China's regulatory system met "WHO-published indicators for a functional vaccine regulatory system."
That first approval made it possible for Chinese vaccine makers to apply for WHO prequalification for specific products. Prequalification is necessary for companies to supply United Nations agencies around the world.
It took two more years for the first such prequalification, but last October the WHO endorsed the safety and quality of a Chinese-made vaccine for Japanese encephalitis manufactured by the Chengdu Institute of Biological Products (CDIBP). It was the first Chinese drug to receive such an endorsement. CDIBP is a division of China National Biotec Group Co. (CNBG), the largest state-owned vaccine maker in China. (See BioWorld Asia, Oct. 23, 2013.)
"We are proud to be the first Chinese manufacturer to produce a WHO-prequalified vaccine," Yang Xiaoming, CEO of CNBG, said at the time.
The WHO approval of China's vaccine regulatory infrastructure expands on that first success, and the WHO's latest move could pave the way for more of China's 30 vaccine makers to receive WHO prequalification. China's vaccine makers produce about 1 billion doses of almost 50 different vaccines, so there is plenty of scope for more approval going forward.
"Even more is expected of China," Chan said. "Outside observers frequently point to China's virtually unlimited potential to produce more and better life-saving health products."