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    Home > Medical News > Latest Medical News > [heavy] it's great! State Food and drug administration, successfully elected as a member of ICH management committee

    [heavy] it's great! State Food and drug administration, successfully elected as a member of ICH management committee

    • Last Update: 2018-06-08
    • Source: Internet
    • Author: User
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    At 1:30 p.m local time, on June 7, 2018, at the first meeting of the International Conference for the technical coordination of human drug registration (ICH) held in Kobe, Japan, China National Drug Administration was elected as a member of the ICH management committee Xiaobian was ecstatic to see the news at the first time! Because today is not only the day when China's national drug administration was elected as a member of the ICH management committee, but also the day when Chinese students rush into the examination room and fight bravely Students have been studying hard for more than ten years, only to sweat in the examination room and to give a satisfactory answer to their youth This is just like that, China's national drug administration was elected as a member of the ICH management committee by virtue of its accumulated strength Next, the editor will give you an overview of the ICH management committee and sort out the arduous process of China National Drug Administration (including the former CFDA) becoming a member of the ICH management committee ICH was founded in 1990 by the United States, the European Community and Japan's tripartite drug regulatory authorities and industry associations The reform was initiated in 2012 Finally, in December 2015, ICH was transformed from a closed international conference mechanism into a technical non-governmental international organization registered under Swiss civil law The basic tenet of ICH is to coordinate and establish international technical standards and norms on drug safety, effectiveness and quality in the field of drug registration technology, as the basis for regulatory authorities to approve drug listing, so as to reduce the cost of drug research and development and marketing, and promote safe and effective innovative drugs to serve patients' health as soon as possible After more than 20 years of development, the technical guidelines issued by ICH have been accepted and transformed by major national drug regulatory agencies around the world, and become the core international rule-making mechanism in the field of drug registration Laying the blueprint: in the afternoon of May 19, 2017, when China strives to join the ICH, Bi Jingquan, director of the food and drug administration, met with Dr Theresa Mullin, director of the strategy office of the center for drug review and Research (CDER) of the US Food and Drug Administration (FDA) and chairman of the Management Committee of the International Conference for the technical coordination of human drug registration (ICH) The two sides exchanged views on promoting drug innovation through regulatory reform and China's accession to the ICH It is hoped that CFDA will join ICH from May 31 to June 1, 2017, and the first meeting of ICH in 2017 will be held in Montreal, Canada The meeting approved the application of the State Food and Drug Administration and formally approved the administration as a member On June 14, with the approval of the State Council, Bi Jingquan, director of the State Food and drug administration, sent a letter to Dr Mu Lin, chairman of the ICH management committee, formally confirming that the State Food and Drug Administration joined the ICH and became the eighth member of its global regulatory body One hundred achievements: SDA became a member of ICH management committee, and SDA was officially established on March 21, 2018 On the way of constantly exploring the standardized management of food, drugs, medical devices, cosmetics, etc., both the former CFDA and the current state drug administration adhere to innovation as the driving force, international standards as the guide, and the road of reform is full of difficulties They are elected as members of the ICH management Committee, which can be said to be popular The successful election of the State Drug Administration will undoubtedly provide the most advanced international technical guidelines and management standards for the domestic drug regulatory departments and pharmaceutical industry, promote the cooperation between Chinese and foreign pharmaceutical enterprises, and improve the strength of drug innovation and R & D of domestic enterprises In addition, in the case that some domestic drugs can not meet the needs of patients' treatment, the significance of election is not only to let foreign innovative drugs enter China as soon as possible, but also to let Chinese drugs enter the international market, so as to carry out the win-win strategy of benefiting the people to the end Some content sources: State Drug Administration, public information
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