China's Food and Drug Administration Becomes a Full Member of the International Technical Coordination Committee for Registration of Medicines for Human Use (ICH)

Release time:

2017-06-19

On June 19, 2017, the State Food and Drug Administration announced that it has become a full member of the International Technical Coordination for Registration of Medicines for Human Use (ICH). It means that China's drug regulatory authorities, pharmaceutical industry and R & D institutions will gradually transform and implement the highest international technical standards and guidelines, and actively participate in the formulation of rules, which will promote innovative drugs to meet the clinical drug needs of patients at home and abroad as soon as possible, and enhance the innovation ability and international competitiveness of the domestic pharmaceutical industry. ICH was established in 1990 by the United States, the European Community and Japan tripartite drug regulatory authorities and industry associations, and in.

On June 19, 2017, the State Food and Drug Administration announced that it has become a full member of the International Technical Coordination for Registration of Medicines for Human Use (ICH).

It means that China's drug regulatory authorities, pharmaceutical industry and R & D institutions will gradually transform and implement the highest international technical standards and guidelines, and actively participate in the formulation of rules, which will promote innovative drugs to meet the clinical drug needs of patients at home and abroad as soon as possible, and enhance the innovation ability and international competitiveness of the domestic pharmaceutical industry.

ICH was established in 1990 by the United States, the European Community and Japan tripartite drug regulatory authorities and industry associations, and in December 2015 from a closed international conference mechanism into a technical non-governmental international organization registered under Swiss civil law.

ICH has built an international platform for regulatory agencies and industry to discuss scientific and technical issues of drug registration. The technical guidelines issued by ICH have become the general technical requirements for drug registration representing the international advanced level. ICH has issued 76 technical guidelines (including regulations on the use of C14 and other radioisotopes in the development of new drugs).

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China's Food and Drug Administration Becomes a Full Member of the International Technical Coordination Committee for Registration of Medicines for Human Use (ICH)

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