China officially joins ICH and truly integrates into the international drug regulatory system

China was excluded from ICH membership for a long time because the drug policies and regulations recognized by my country are largely in accordance with the standards of the WHO (World Health Organization). The WHO is considered the lowest standard in the world, while the ICH is the lowest standard for developed countries. But when China joined the WTO in 2001, it included a commitment to align drug quality with international standards.

On June 1, local time, at the venue in Montreal, Canada, the State Food and Drug Administration (CFDA) had just officially become a member of ICH. "The official announcement will be released in two weeks." An ICH policy expert in North America revealed the news to Southern Weekend reporters as soon as possible. They received an email of formal approval a few hours ago.

ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, was initiated in 1990 by the government drug registration departments and pharmaceutical industries of the United States, Japan and the European Union. The main purpose is to coordinate the standardization of the global drug regulatory system - similar to the role played by the WTO in trade among countries. This means that "China's drug regulatory system has truly been integrated into the regulatory system recognized by the international community."

Dr. Theresa Mullin, Director of the Strategic Office of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA), said that on October 23, 2015, ICH was reformed to establish a new association. The reformed ICH is no longer based on countries. Qualified organizations that meet certain standards can apply for membership and observer status of ICH. China also submitted a membership application after this reform.

"The original intention of establishing ICH is to standardize the chaotic and independent drug regulatory systems of many countries, so that many countries can follow the same methods and approval procedures for approval work. Its purpose is to allow the products of ICH member countries to be mutually certified as soon as possible. Because different countries have different requirements for drug registration, this is not only not conducive to patients getting scientific guarantees in terms of drug safety, effectiveness and quality, and international technology and trade exchanges, but also causes waste of manpower and material resources in the pharmaceutical industry and scientific research and production departments, which is not conducive to the development of human medicine." Dr. Theresa Mullin explained.

At the 2017 China International Drug Information Conference (DIA) ten days ago, Yuan Lin, Director of the International Cooperation Department of the State Food and Drug Administration, also sent a relevant signal: "my country submitted an application to join ICH conditionally in March this year." At that time, he said that the time for China to join ICH was basically ripe, and now was a very appropriate time. By joining ICH, we can better strengthen international exchanges and cooperation, help my country's drug review and approval system reform, and better promote drug research and development innovation. This is also based on the fact that the State Food and Drug Administration has actively participated in ICH activities and the formulation and revision of relevant international standards in recent years, and has transformed and borrowed more than 20 technical guidelines of ICH for application in my country's drug technical review. Industry insiders at the conference believed that China's drug regulatory authorities can no longer fight alone, because what China's current pharmaceutical industry really needs to improve is to establish an equal, smooth and efficient communication system based on scientific research and scientific supervision, not only between regulatory authorities and the industry, but also within regulatory authorities and between international regulatory systems. Once joining ICH, higher requirements will be placed on China's regulatory authorities and all aspects. Dr. Theresa Mullin, who was also at the conference, expressed her full support for China to join ICH as a formal member. Dr. Mullin said: "I believe that ICH also needs China to become a member, because China's pharmaceutical market has grown rapidly in recent years, and without China, about 20% of global recognition will be excluded. Joining ICH also means that China will accelerate its internationalization."

The core of ICH is that developed countries set standards for other countries to accept, so there is a saying in the industry that "first-class countries set standards, second-class countries produce and sell products, and third-class countries provide raw materials." This situation is most obvious in the IT and communications industries, with prominent examples being Microsoft's computer operating system and Google's mobile phone operating system.

China was excluded from ICH membership for a long time because the drug policies and regulations recognized by our country largely follow the standards of the WHO (World Health Organization). The WHO is considered the lowest standard in the world, and the ICH is the lowest standard for developed countries. But when China joined the WTO in 2001, it included a commitment to the need for drug quality to be in line with international standards, including a series of clauses such as protecting drug intellectual property rights, reducing drug import tariffs, opening up drug distribution services and opening up the market for medical services.

"Joining ICH is just the beginning," said Dr. Su Ling, venture partner of Lilly Asia Ventures and professor at Shenyang Pharmaceutical University. As the world's second largest pharmaceutical market, China's drug R&D potential is growing rapidly today. Joining ICH can provide a lot of beneficial information to the system. In this sense, "China needs ICH, and ICH also needs China."