Speech: WHO assessment of China’s national drug regulatory authority for vaccines
Dr Margaret Chan, Director-General of the World Health Organization
China’s regulatory system on food and drugs from a global perspective
Beijing, China
4 July 2014
Excerpt
Minister Zhang Yong, colleagues and friends, ladies and gentlemen,

Let me begin by extending my warm congratulations for a job well done. I have just announced that the China Food and Drug Administration’s regulatory system for vaccines has been assessed by WHO with outstanding results.

You have met established benchmarks that define international requirements for a functional vaccine regulatory system. The improvements made since the previous assessment are most encouraging. CFDA is well on its way towards meeting the highest international standards for a regulatory authority.

I just had a most productive meeting with Minister Zhang Yong. I am delighted to inform you that we signed a declaration of joint commitment. We will work together to make CFDA an advanced, internationally recognized regulator not just of vaccines, but also of medical products and food safety management.

Effective regulatory oversight of vaccines is especially important, as vaccines are used on a population-wide basis, and are usually given to healthy infants. High quality must be assured.
The results of the WHO assessment are good news for China, but also for the rest of the world. The demand for vaccines is increasing at a time when the number of countries producing vaccines is declining. China has the largest vaccine manufacturing capacity in the world.

With the latest seal of approval from WHO, this country is in a position to make high-quality vaccine supplies more abundant, predictable, and affordable. This capacity benefits all countries, but most especially in the developing world. It strengthens China’s long history of collaboration to improve health in Africa…