China has long been excluded from ICH membership because its recognized drug policies and regulations largely comply with WHO (World Health Organization) standards. The WHO is considered the global minimum standard, while the ICH is the minimum 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 1st local time, at the Montreal venue in Canada, the National Food and Drug Administration (CFDA) has just officially become a member of the ICH. "The official announcement will be released in two weeks." An ICH policy expert in North America revealed the news to the reporters of Southern Weekly at the first time. They received the official email a few hours ago.
ICH, also known as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, was established in 1990 by government drug registration departments and the pharmaceutical industry in 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 integrated into the regulatory system recognized by the international community.
Dr. Teresa Mullin, director of the Strategic Office of the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA), said that on October 23, 2015, ICH was reformed to establish a new association. The reformed ICH is not a country based organization. Qualified organizations that meet certain standards can apply for membership and Observer status status of ICH. China has also submitted membership applications after this reform.
The original intention of establishing ICH is to standardize the drug regulatory system that is chaotic and integrated in multiple countries, and to ensure that multiple countries follow the same methods and approval procedures for approval work. The purpose is to enable ICH member countries to quickly authenticate their products to each other. Because different countries have different requirements for drug registration, this not only hinders patients from obtaining scientific assurance in terms of drug safety, effectiveness, and quality, but also international technology The exchange of technology and trade also causes waste of manpower and material resources in the pharmaceutical industry, scientific research, and production departments, which is not conducive to the development of human medicine Dr. Theresa Mullin explains.
At the 2017 China International Drug Information Conference (DIA) ten days ago, Yuan Lin, Director of the International Cooperation Department of the State Administration of Food and Drug Administration, also issued a relevant signal: "China submitted a conditional application to join ICH in March this year
At that time, he said that the time for China to join ICH was basically ripe. Now is a very appropriate time. By joining ICH, we can better strengthen international exchanges and cooperation, help reform China's drug review and approval system, and better promote Drug development innovation. This is also based on the active participation of the State Food and Drug Administration in ICH activities and the formulation and revision of relevant international standards in recent years, which has been transformed