China officially joined the ICH, marking its real integration into the international drug regulatory system

China officially joined the ICH, marking its real integration into the international drug regulatory system

Recently, China Food and Drug Administration (CFDA) has submitted its membership application to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonisation or ICH), marked its integration into the internationally recognized regulatory system.

ICH was co-launched by regulatory agencies and industry associations from the United States, Japan, and the Europe in 1990, with the goal of standardizing the international drug regulatory system – similar to the role of the World Trade Organization (WTO) in trade among countries.

“ICH was reformed to establish a new association.” Dr. Seresa Mullin, Director of the Strategic Office of Drug Review and Research Center of the US Food and Drug Administration (FDA) said during a hearing on October 23rd, 2015. “After the reform, any organization, which meets its requirements and standards, is eligible to apply to become a member or observer of ICH. “

The original intention of the ICH is to standardize drug regulatory systems of different countries, in the hope that ICH members can comply with the same method and approval procedure to speed up the mutual certification among them. At present, most countries follow their own drug registration requirements, which is not only detrimental to maintain the safety assurance, efficacy, and quality of drugs across the world, but also hurdles the international technical and trade communications and exchanges. In addition, it also causes wastes in productions and human resources, as repeated clinical trials are carried out among countries to suffice their own regulatory standards.

“It is a very good time for China to join ICH now.” commented by Lin Yuan, the director of International Cooperation Department at CFDA. “By joining the ICH, China is poised to increase its international exchanges and collaborations, which in turn can help the reform of China’s drug review and approval system and to further accelerate innovations and new drug researches. “

In the recent years, CFDA has been actively participating in ICH activities and the revision of international standards, from which it has learned and applied more than 20 technical guidelines to its own drug and technology review process.

Currently, the most urgent need of the Chinese pharmaceutical industry is to establish an equal, smooth, and efficient communication system, which not only can be applied to facilitate conversations between Chinese regulators and the industry, but also among the Chinese and international regulatory systems. Clearly, CFDA can no longer go alone, joining ICH is an unavoidable path, which will put more pressure on its current regulatory system, and at the same time, drive it to meet higher standards.

China has received tremendous supports across the globe, since its move to follow ICH standards. “I believe ICH also needs China; without China, it rules out about 20% of the global market. This is especially true at current environment, where the Chinese pharmaceutical industry has been growing at a significant speed in the past few years.” commented by Dr. Mullin.

On another note, China is also accelerating the pace of ICH’s internationalization, as its core concept is that developed countries define the standards for other countries to follow. This is being said, first-class countries set up the rules; second-class countries produce and sell products; third class countries provide raw materials. China’s participation undoubtedly will further facilitate this process.

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