Speech on China’s successful national
regulatory authority re-assessment
Beijing, China, 4 July 2014

Minister Zhang Yong, friends and colleagues, ladies and gentlemen,

I have two pieces of very good news.

First, 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 the China Food and Drug Administration an advanced regulator not just of vaccines, but also of medical products and food safety management.

Second, the China National Regulatory Authority for vaccines has been carefully evaluated by WHO regulatory experts and determined to be functional, having met or exceeded all WHO standards.

The strong evaluation result is a significant achievement for governmental regulators in China.

These outstanding results give me full confidence in the safety and effectiveness of vaccines that are made in China.

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.

I am confident that China’s children are receiving high-quality vaccines that meet international standards of production, safety, and effectiveness.

I am confident that children around the world will benefit as Chinese companies make vaccines more abundant, more predictable, and more affordable.

Last year, I had the pleasure of announcing that a vaccine against Japanese encephalitis, made in China, was prequalified by WHO.

Japanese encephalitis is the leading viral cause of disability in Asia, killing or causing neurological disabilities in 70% of those it infects. 

The job of regulatory oversight rests with government, working with vaccine manufacturers, to assure that vaccines are safe and effective, and are produced according to the latest internationally-recognized Good Manufacturing Practices, as established by WHO.

This is an immense job, with immense importance.

A vaccine regulatory authority oversees every step of the journey that a vaccine takes, from approving clinical trials of safety and effectiveness, to approving the manufacturing facilities and equipment, to approving the manufacturing processes.

Only then is a vaccine licensed and allowed on the market.

The responsibilities of the regulatory authority do not stop there. They continue throughout the life of the vaccine.

Every batch of vaccine that is produced is tested chemically and biologically for quality assurance before its release for use. 

The safety of vaccines already in use is also monitored using a reporting system that identifies adverse events following immunization.

If a problem is identified, the regulator has the responsibility and authority to intervene to assure the problem is fixed.

The most recent WHO evaluation means that all these functions are being performed at a level that meets or exceeds international standards.

This is a tribute to a great deal of hard and dedicated work that benefits the children of China and the world.

Thank you.