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

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.

This achievement took a lot of dedication and hard work on your part. Its significance is profound.

You have demonstrated China’s commitment to producing high-quality health products, its contribution as a major player in global health, and its engagement as a partner for development. In short, this is a source of national pride.

Even more is expected of China. Outside observers frequently point to China’s virtually unlimited potential to produce more and better life-saving health products.

Let me give you just one example. Last year, WHO prequalified the first vaccine, for Japanese encephalitis, made in China. The Chinese vaccine was not only less expensive than vaccines already on the market. It was a better product.

It is easier to administer, being effective after a single dose, and it can be safely given to infants, vastly simplifying the logistics of vaccine delivery and cutting costs even further.

The prequalification of this vaccine by WHO made headlines as a true game-changer for a disease that is the leading viral cause of disability in Asia. Japanese encephalitis kills or causes neurological disabilities in 70% of those infected.

The door is now open for CFDA to prequalify, with WHO support, many more vaccines made in China.

China is further recognized for its leading role in the manufacturing of medical devices that perform well at a fraction of the cost of equipment manufactured elsewhere. Examples include scanners that cost $10,000 rather than $100,000, and portable electrocardiographs that cost $500 instead of $5,000.

WHO estimates that 85% of deaths from heart disease, cancer, and diabetes now occur in low- and middle-income countries. Making such devices affordable for the developing world is a huge contribution to global health. A country like China that has lifted so many millions of its people out of poverty knows the importance of affordable products.

Rest assured. WHO is fully committed to support China as this country continues to harmonize its regulatory system with the highest international standards.

This is the vision of CFDA, and we have joint formal plans for realizing this vision.

Ladies and gentlemen,

Populations expect their governments to protect them from hazards to health, including hazards arising from tainted food and sub-standard medicines.

In advanced societies, the public assumes that the air they breathe, the water they drink, the food they eat, the medicines they take, and the chemicals they use in homes or at the workplace will not damage their health. Ensuring safety in these areas is a hallmark of good government, and it inspires confidence in government.

Regulation is among public health’s most powerful preventive tools. Regulatory capacity underpins some of the best work done to safeguard public health. Good regulatory capacity, backed by strong enforcement, confers population-wide protection in an efficient and cost-effective way.

The power of regulation extends beyond ensuring the quality and safety of foods and medicines.

Many of the biggest threats to health in the 21st century, including chronic noncommunicable diseases, have causes that reside in non-health sectors. Legislation is one of the best ways to reduce risk factors and keep the public safe.

Legislation and enforcement are central to the prevention of road traffic crashes, which claim more than 1.2 million lives worldwide each year.

Reducing the harmful use of alcohol depends on the concerted action of national authorities, traffic police, licensing officers, the criminal justice system, and safety authorities, in addition to health officials.

Tobacco control, which needs to be a top priority for China, likewise depends on legislation that aligns as closely as possible with provisions in the WHO Framework Convention on Tobacco Control. As abundant evidence shows, increasing taxes on tobacco products is the most effective way to reduce demand.

Of all these functions, the regulatory control of food and medicines brings the widest benefits. Everyone needs to eat, and everyone needs medicine.

The challenges CFDA faces are growing ever more complex, entangled as they are in the intricacies of food and pharmaceutical trade in a world of radically increased interdependence.

WHO and its Member States have struggled for years to find ways to protect national and international pharmaceutical supply chains from substandard, spurious, falsely-labelled, falsified, and counterfeit medical products.

Medicines for malaria illustrate this problem well. A recent study examined samples of malaria medicines from several countries in South-East Asia and sub-Saharan Africa. In both regions, 35% of the samples failed chemical analysis. In South-East Asia, 36% of these samples were classified as falsified.

Outbreaks of foodborne disease have become an especially large menace. They are large in their potentially wide geographical spread, often involving multiple countries. They are large in the costs of recalls measured in the tonnes. And they are large in the complexity of investigations, especially when a meal may contain items and ingredients from all around the world.

Today, problems can arise from any link in a convoluted food chain. Adding to the complexity is the increasing use of formerly exotic cuisines where ingredients like, say, a sprinkling of radish sprouts, are almost subliminal and are unlikely to be recalled in a food history.

Foodborne diseases always cause considerable collateral damage to the food industry. Consumer fears and costly reactions can linger long after the risk itself has been removed.

In Europe, consumers drastically reduced their consumption of beef long after the outbreak of bovine spongiform encephalitis, or mad cow disease, was officially contained. Many farmers were ruined, even in countries that did not report a single case.

Outbreaks of foodborne disease can also cause a political uproar, especially when the outbreak is international and blame is placed on an individual country with lapses in its system for regulatory control.

It takes years to build consumer confidence in a government’s ability to keep the food supply safe. That confidence can be lost in a matter of days and can prove enormously difficult to re-establish.

Ladies and gentlemen,

These days, safeguarding public health means acting on a global stage. It also means moving from a reactive to a proactive response, and taking on all the important, yet sometimes politically delicate work this entails.

Something similar happened when the International Health Regulations, administered by WHO, were revised in 2005. Central to the revision was a move from a reactive response, aimed at blocking international spread at borders, to a proactive response that aims to stop a health threat at its source, before it has a chance to spread internationally.

Ebola virus disease continues to spread in West African countries, but China has kept cases of H7N9 largely confined within its borders. This is another example of highly responsible behaviour on the international stage.

Our interdependent and interconnected world makes it imperative to align national technical quality standards for food and medical products with internationally-recognized standards, especially those issued by WHO. This protects health and facilitates international trade. But it also protects a nation’s international reputation.

As this most recent CFDA assessment demonstrates, China is on its way towards establishing a world-class regulatory authority that can serve as a model for other countries.

As the world’s most populous country, China faces some unique challenges, also arising from the wide diversity of this population in income levels, education, and cultural behaviours. But China also has more experts than any other middle-income country. In fact, some of the world’s best experts are here in this room.


I began my remarks by referring to CFDA’s ambition to become a global leader in the regulation of vaccines, medicines, and food safety.

Ambitious yet feasible goals are the best way to build on success, but they also demand great courage and determination.

You will encounter many challenges along the way. You will need to change not only the way you work, but also the way you think.

You need a clear-eyed look at the international standards you want to meet, even to surpass, and then a hard-headed assessment of your strengths and weaknesses.

Rest assured. WHO will be your constant partner at each stage as you work to realize these high ambitions.

Thank you.

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