Release date: 2014-11-24

Recently, Dr. Margaret A. Hamburg, Director of the US Food and Drug Administration (FDA), gave a speech at Peking University on the theme of “Addressing Global Challenges, Strengthening International Collaboration, Promoting Health and Safety”. The following is the full text of her speech.

Thank you for your kind introduction. I am very happy to visit China again. I am especially honored to be able to visit Peking University again. Thanks to the distinguished officials, faculty and students, and the hospitality of the beautiful campus.

Your school has a long and glorious history as a center of research and scholarship, cultivating and bringing together many of the country's great leaders and thinkers. Your academic reputation is well-received, and it contributes to promoting academics and nurturing the next generation of leaders. I believe that many of them are on the scene today.

As everyone knows, higher education institutions are not defined solely by their curriculum. This is another reason why this university is outstanding – advocating erudition, honesty, and the value of academic and intellectual freedom, which embodies and enriches the essence of teaching, research, and learning.

As the great American educator Robert Maynard Hutchins puts it, “The purpose of education is to let young people self-educate for life.” Everyone is building this foundation, and the hope lies in everyone’s endeavor to internalize education for life. Among them.

So I am here to meet you today, and it is worthwhile. I have revisited China this week and there are other things. From tomorrow until this weekend, I will be attending the 9th International Summit of Drug Regulators Summit, which provides a solution to common public health challenges, sharing emerging knowledge, discussing regulatory challenges and potential areas of international cooperation. Important opportunity. I am encouraged by the leadership role played by the China National Food and Drug Administration (CFDA) in organizing and organizing this important multilateral conference.

I will also meet with a number of Chinese officials to discuss other ways to strengthen our partnership between the two countries, strengthen food safety in China and export to the United States, and strengthen pharmaceutical products produced in China and used for export to the United States. Quality and effectiveness. We will also discuss how to improve everyone's health and safety through the joint efforts of all of us.

I believe that this is a manifestation of the growing importance and close relationship between our two countries – and that is how we take seriously the regulatory issues of food and pharmaceutical products – just two weeks before my visit, the FDA is responsible for food and veterinary medicine. Deputy Director Michael Taylor officially visited. Just last week, when President Obama visited the APEC Leaders Summit, his entourage kept our regular contacts with members of the FDA China office as we worked to expand our presence in China.

So we have deep relationships across multiple levels of government. We also have technical cooperation. For example, I look forward to the opportunity to visit a counterfeit product mobile testing laboratory tomorrow, a resource that will help us work together to prevent counterfeit drugs.

Although I have been to China in 2012, I had a short trip last summer, but the last time I visited your school was in 2010. At that time, I was just a secretary, and I was familiar with the institution that President Obama chose to lead. At that time, I just began to understand the breadth of the FDA's mission and the enormous influence of responsibility.

The FDA ensures the safety, efficacy and quality of human medicines, veterinary drugs, medical devices, human biological products and blood supplies in the United States. We oversaw cosmetics, food additives, and radiation products and began to be responsible for tobacco product regulation five years ago. Of course, the FDA is responsible for overseeing the vast majority of food supplies, as well as investigating foodborne disease outbreaks and mitigating losses.

In addition, the FDA promotes accelerated innovations that make drugs and devices safer and more effective. Ensuring public access to accurate, science-based medicines, device use and food information to promote public health.

All of this means that the FDA is responsible for overseeing an estimated $3 trillion worth of pharmaceutical products, food, cosmetics, food additives and tobacco each year. In the US, for every dollar spent on consumer goods, we oversaw more than 20 cents.

Needless to say, the scope and responsibility of the FDA's responsibilities – coupled with the extraordinary potential of today's technology, has changed the prevention, diagnosis and treatment of disease and public health challenges – meaning that when I came here When an institution is concerned, it must be prioritized. A top priority from the very beginning is related to the growing challenges of globalization, which have a huge and direct impact on the FDA's mission.

The new reality of the production and circulation of food and pharmaceutical products used in consumers' daily lives has dramatically changed our world today, and such changes are accelerating. Between countries at both ends of the world, interactions are taking place in ways that have never been seen in half a century or a century ago. Even a decade ago, the world at that time was quite different from the present.

The growing relevance of global supply chains is a good thing in many ways. All of us are able to get a variety of products that we have never had before. But it also poses many new threats to our health and safety. Today no food or pharmaceutical products are protected from the flow of products along such global manufacturing, processing, packaging, production and transportation pipelines. This complex system has made these products vulnerable to threats that threaten their safety and security.

Today, I want to talk to you about the threats we face in this new environment, as regulators, where we can make a difference – through domestic efforts or growing cooperation between nations – to address and overcome these threats.

But this is not just about working together. Our work must also make full use of the advantages and conditions of continuous technological advancement to help us fulfill our mission of promoting and protecting public health.

I would like to cite an early case in which global issues are intertwined with pharmaceutical products. For example, rhubarb, which is not in the forbidden, was found to have important medicinal properties in 1100 AD – or earlier than this. Rhubarb was very popular as a laxative or laxative because of its important therapeutic function in line with the medical system of that era. In particular, Chinese rhubarb is regarded as a treasure. For centuries, China has been a major importer and exporter, selling all over the world along historical trade routes.

Perhaps not surprisingly, other countries have begun to seek restrictions and regulate the rhubarb. For example, in the late 1680s, the Russian government imposed controls on the rhubarb trade. In the early eighteenth century, restrictions were imposed to improve quality, and it was mandatory to eliminate the so-called "inferior or counterfeit goods," which stipulated that the roots should be dried and packaged in a waterproof box to avoid moisture before the pharmacist was sold. Who ever thought that there would be so much attention to rhubarb?

The reason for citing this case is that on the one hand it shows some intrinsic problems surrounding the rhubarb dispute – supply and demand, production and regulation, product quality and efficacy – these issues are still at the heart of many global trades in pharmaceutical products.

Quoting this case also lies in fundamental differences from today's global market. First, the challenges we face in relation to the manufacture, distribution and regulation of pharmaceutical products are far more than ever. Thanks to innovations in manufacturing, transportation, refrigeration and communications, today's production and distribution is huge and complex. In addition, advances in technology – and information related to these breakthroughs – make even more complex products easier to manufacture. As a result, many countries that have never dreamt of becoming a producer or seller of pharmaceuticals, medical devices or biological products have been able to squander these products globally and sell them globally today.

These changes have had a huge impact on the role and responsibilities of the US and the FDA. More than a century ago, when the FDA was created, we focused primarily on the domestic market, and the regulated industries were essentially local. But today, not only does the number of products we oversee grow exponentially, but these products are increasingly coming from outside the United States in whole and in part.

Among the products regulated by the FDA, only fewer products are manufactured and distributed in the United States. In contrast, FDA-regulated products come from more than 300 different countries and more than 300,000 production facilities around the world. For example, in China alone, there are nearly 4,000 medical device manufacturers registered with the FDA, producing nearly 20,000 registered devices.

Today, about 40% of the finished drugs used by Americans are produced in other countries, and about 50% of the medical devices used by Americans. About 80% of the APIs used in the United States are outside the United States.

Some countries have shown particularly significant growth. For example, India, Mexico and Thailand have achieved significant growth in both quantity and variety of products. Of course, in recent years China has experienced a significant expansion in the production and export of pharmaceutical products.

For example, today, China has become the world's largest supplier of APIs and certain additives for pharmaceuticals. For example, China is the world's largest producer of acetaminophen. This drug is widely used as an analgesic. China is also the world's leading producer of vitamin C. It manufactures more than 100,000 tons per year, of which about 90% is exported.

Indeed, China's dynamic pharmaceutical and pharmaceutical products industry has played an important role in the historic economic development of the past few decades. Equally important, these inputs from the public and private sectors – and in other ways – are a very important reward for advancing global health. A number of organizations, such as the World Health Organization, the Gates Foundation and other key stakeholders, are working directly with China to provide low-cost, safe and effective essential medicines and vaccines to developing countries.

However, although the pharmaceutical products produced in China are used all over the world, the proportion of flows to the United States is the highest. For pharmaceutical products, including pharmaceuticals, biological products and medical devices, China has clearly become one of the most important partners in the United States. In 2013, the total amount of medicines exported from China to the United States was about 4 billion US dollars, most of which were raw materials. In contrast, the total amount of US drugs exported to China is $1.22 billion.

China is currently ranked sixth in countries that export drugs and biological products to the United States. China is also the number one exporter of medical equipment and equipment to the United States.

In the modern, globalized world, many very positive aspects of this growth are obvious. Of course, the American people also benefit from the global procurement of pharmaceutical products purchased from China and other regions.

But the quality and safety deficiencies from these products also pose potential risks. Indeed, at every stage of today's increasingly complex global supply chain network, the risks become even greater. Sometimes such risks are the result of lack of quality control, affecting formulation, packaging, or causing pollution. Sometimes these hazards stem from deliberate stocking, counterfeiting or doping.

As you can imagine, process development in production processes spans not only different factories or farms, but also across countries, which means that the burden of regulators responsible for ensuring safety and safety and the effectiveness of these pharmaceutical products is increased.

These changes mean that the number of products on the global supply line has soared, and it has become a bigger challenge to confirm that product managers and products are properly manufactured, circulated and stored. This shift means that it can no longer function as before, relying heavily on inspectors who perform missions at national ports of entry to ensure product safety in a country.

How do we respond to the challenge of ensuring that our citizens buy and use products that are safe, healthy, and perform as expected?

To some extent, the answer involves using new, advanced technologies and better analytical methods to enhance and make existing methods more effective. For example, while products are currently being screened at entry points, regulators are increasingly using risk-based analytics and sophisticated algorithms to classify goods, determine product properties, and apply comprehensive risk knowledge.

However, in today's global business world, even these more sophisticated inspection methods alone are not enough to ensure quality and safety. It is necessary to take part in the process before the product arrives at the border of the country to which it is sent, and take precautions. From the source, there is a need to establish a presence and a new understanding in the exporting countries of these products.

The FDA has been working hard to strengthen its capabilities beyond the US border and work with counterpart regulators in other countries. As part of this effort, we are helping to build a stronger system that oversees the R&D and distribution processes in these countries and helps ensure the existence of the necessary quality and safety controls.

To achieve this, the FDA is required to transform from a domestic regulatory agency operating in a globalized world to a truly global vision to prepare for the risks involved in product manufacturing, regardless of whether the process takes place in the world. Go anywhere. We have been working hard to improve it in different ways.

For example, in 2012, through the Food and Drug Administration Safety and Innovation Act (FDASIA), the US Congress granted FDA additional authority to prevent, detect, and respond to areas and improve supply chain security. Expanded authority in the area of ​​safeguards and integrity. Among the grants granted, including the explicit authorization of the FDA to work with foreign regulators, the FDA is able to make full use of resources through information sharing and accreditation of regulatory authorities.

In the past 10 years, we have also opened a number of overseas offices, including the opening of a Chinese office. Here, I would like to pay tribute to Dr. Christopher Hickey, Director of the FDA China Office, and all my colleagues for their efforts here. These job placements have proven to be very important for inspection planning for foreign facilities and manufacturing plants.

However, perhaps more importantly, our office here serves as a center for cooperation with China's counterpart regulators and Chinese industry for information exchange and information exchange. For example, we work closely with a number of Chinese institutions to build regulatory capacity and share best practices – including by promoting FDA training in key regulatory areas.

In collaboration with CFDA, international regulators and other professional organizations, Dr. Wang Gang from the China office held several seminars and training sessions on risk-based GMP inspections to ensure the safety of Chinese manufacturers manufacturing and exporting drugs to the United States. quality. More than 1,000 CFDA regulators and drug inspectors participated in these seminars and trainings.

As the pharmaceutical products industry matures, China faces some challenges, including the need to improve compliance and quality systems and strengthen production quality practices. Some of these challenges are due to the creation of many small companies that do not have a suitable system in place to ensure production quality practices.

It is not only China that faces the risks brought about by the growth of the pharmaceutical products industry. Quite simply, many countries are experiencing this large-scale capacity expansion under the conditions of a mature regulatory framework that is critical to ensuring the safety and security of manufacturing and distribution processes. Sometimes there is a lack of financial and human resources to build and maintain such a regulatory framework. Sometimes the challenge comes from the complexity of the product itself and the lack of regulatory science training. Sometimes there is public pressure to deregulate.

Lack of adequate regulation, for any reason, such failures expose consumers to unacceptable risks, but also threaten the country's economy and security... frankly, it also affects other countries. That's why we are working together to expand partnerships between countries, improve information sharing and data collection, and make the most of resources.

It is commendable that China is committed to strengthening its regulatory system in a fast and impressive way, and the US FDA has established a strong relationship with China. At all levels, we continue to enhance cooperation between the two countries, including in industry, R&D and academic institutions, and between our government and regulatory agencies. Our goal is to be consistent – ​​to ensure that products manufactured in China and exported to the United States are of high quality and safe and effective for consumers. For example, in 2007, the US Department of Health and Human Services (HHS) and the Chinese government concluded two unprecedented agreements, and the FDA is a subsidiary of HHS. These two agreements are officially marked in food and A new era of feed safety, drug and medical device safety cooperation and the establishment of a regulatory cooperation mechanism.

Under these agreements, the United States and China agree that in the event that a public health hazard is discovered, such as a product recall, they should be notified as soon as possible. In addition, Chinese regulators will require product registrations for export to the United States and are committed to building systems that ensure compliance with FDA standards before they are exported.

During his visit to China last year, Vice President Biden affirmed the importance of cooperation in these areas. China promised to issue visas to the additional FDA food and drug inspectors.

In order to achieve this goal, we have worked closely with China and finalized two arrangements to further promote the cooperation channels and methods established in the 2007 agreement. By defining an information exchange framework and documents related to inspections, these two agreements have led to the further development of our relationship, enabling the two regulators to obtain regulatory decision information.

There are also many other ways of successful cooperation between the two countries. For example, in May 2012, the FDA took enforcement action against more than 100 websites. The FDA has previously determined that these websites sell fake food additives and pharmaceutical products to Chinese and US customers. The FDA's Office of Criminal Investigations (OCI) investigates these sites and shares information with counterparts in China. OCI also provided CFDA with an open source Internet survey training course, and we continue to work together to combat cybercrime in a variety of other ways.

But our collaborative efforts are not just about law enforcement issues. Chinese regulators have become an important strategic partner of the FDA. Today, from the sharing of clinical trial information, which may affect consumer safety issues, to medical advances in key health areas, we regularly engage with important issues.

For example, late last year, the FDA licensed several genetic sequencers to market. The FDA China office then passed this information to the CFDA contact. As a result of this exchange, the CFDA recently issued requirements to strengthen regulations related to gene sequencing, these new requirements reflect information learned from FDA experience.

Finally, there is no mention of another very important and successful collaboration that I am proud of – this is the collaboration between the FDA China Office, the FDA Center for Drug Evaluation and Research (CDER) and this great university. This is the creation of a world-class International Pharmaceutical Engineering Management (IPEM) graduate degree program to foster future leaders in the Chinese pharmaceutical industry and accelerate industrial modernization.

This collaboration began in 2005 with two current quality standards for pharmaceutical production. These courses have been highly successful, have attracted the attention of many Chinese pharmaceutical companies and regulatory agencies, and have attracted the attention of industry and regulatory agencies in many countries.

In the second year, Peking University created the IPEM Master's degree program with the help of the FDA and a number of multinational pharmaceutical companies. Launched in March 2007, the program combines international standards such as regulatory science, pharmaceutical science, engineering science and business, management and leadership.

These collaborations are worthy of attention, and equally important is the fundamental purpose of this collaboration – to develop a new generation of highly trained professionals who understand how to comply with international standards for the Chinese pharmaceutical industry and regulators. This is also in line with the university's overall curriculum and the goal of cultivating government sector leaders and private industry leaders.

In the direction of strengthening the field of regulatory science, by training new thinking, with this new thinking, we can formulate, develop and develop the science and standards needed to ensure the safety, research and development speed, food and approval of new medical products that have an impact on patients' lives. And tools, the IPEM project has made great progress. This is the forward-looking thinking we hope to ensure the highest standards of regulatory and scientific standards in the future of a global economy.

As our two countries continue to strengthen bilateral relations, we must also establish a global governance system that provides a broader collaborative mechanism. This vision has ignited great interest and enthusiasm from regulators, regulated industries and other stakeholders.

I am pleased that we have already had such institutions in place or in growth, including the newly established International Federation of Drug Regulatory Agencies (ICMRA), the International Coordinating Committee (ICH), and the Drug Inspection Cooperation Program (PIC/S). And the International Drug Regulators Forum.

Because of the efficiency and information sharing that can be promoted, it makes sense to establish such a global approach to governance. By creating a more coordinated path between global manufacturing facilities, we can provide standards, ensure quality levels, and leverage financial resources and expertise.

But there is another very important reason for building and strengthening regulatory capacity in developing countries, beyond ensuring product quality and enhancing consumer safety. By improving domestic health and productivity and supporting reliable industrial and economic growth, we have the opportunity to provide these countries with the benefits of important and lasting health and economic development.

As I said before, no matter where the threat to health occurs, no one can be alone. From the case of Ebola raging, we have a deep understanding. The challenge of globalization is not just about business and trade issues. It is also directly related to how we share our views and solutions to serious health problems that many countries may face alone – and ultimately will affect the entire world that is increasingly connected.

We are beginning to witness some success in meeting these global health challenges through the conferences we will be attending here this week, through our established partnerships between our two countries, through the global governance system we are building across the world.

I look forward to continuing to develop partnerships with China and look forward to working with other countries to create a stronger system that meets the growing needs of the globalized world and helps ensure the health of all residents, no matter where they live. country.

I also look forward to seeing the influence of the students of this university in the future. I believe that with our enthusiasm, wisdom and leadership, we can achieve unrestricted achievements. I hope that all of us can truly realize the promise of globalization and, by doing so, improve the health and safety of all of us.

thank you all.

Source: Lin Lin Information

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