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    Home > Active Ingredient News > Drugs Articles > BRICs countries will form a memorandum of understanding on cooperation to strengthen drug supervision

    BRICs countries will form a memorandum of understanding on cooperation to strengthen drug supervision

    • Last Update: 2017-07-14
    • Source: Internet
    • Author: User
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    Source: pharmaceutical economic news July 14, 2017 pharmaceutical network July 14 July 13, the "2017 BRICs drug regulatory cooperation conference" sponsored by the State Food and Drug Administration and co organized by China Pharmaceutical Association and organized by Henan food and drug administration was held in Zhengzhou The reporter learned at the meeting that the State Food and drug administration has achieved remarkable results in consolidating and deepening bilateral cooperation between governments As of June 2017, the State Food and drug administration has established daily working contacts with regulatory agencies in 66 countries and signed 42 bilateral cooperation documents with 28 countries and regions In his speech, Wu Zhen, deputy director of the State Food and drug administration, pointed out that since the BRICs countries held a separate drug regulatory cooperation meeting in 2015, it has provided a platform for regular communication with each other, informing them of the latest regulatory policies and requirements, seeking the other link of the regulatory chain, seeking common ground while reserving differences, increasing credit and resolving doubts, and achieving win-win cooperation, balanced development and common security The State Food and drug administration is focusing on the concept of "win-win cooperation", "balanced development" and "common safety" international cooperation, constantly expanding channels and fields of international exchanges and cooperation, building platforms, upgrading levels, learning from advanced international regulatory concepts and experience, improving the ability of drug safety assurance, and promoting the internationalization of drug regulatory work At the International Conference on drug regulation, director Yuan Lin of the State Food and Drug Administration (SFDA) said that CFDA actively participated in international organizations and multilateral rules making and revision mechanisms First, after a long and arduous negotiation, at the ICH conference held in Montreal, Canada, in June 2017, the General Administration officially joined the ICH as a member, which is the international community's reform of the drug review and approval system of the Chinese government and medicine The recognition of industrial development means that China's regulatory authorities, pharmaceutical industry and R & D institutions have officially joined the highest international rules and standards organization in the field of drug registration Second, the General Administration and the World Health Organization have closely carried out all-round cooperation, successfully passed the evaluation of vaccine regulatory capacity, actively promoted the pre certification of drug vaccines and in vitro diagnostic reagents, set up the cooperation center of chemicals, biological products and traditional drugs, and comprehensively improved regulatory capacity around its global benchmark evaluation indicators to reach the international advanced level Third, the general administration actively participates in the international drug regulatory body alliance and medical devices The work of international organizations such as the regulator forum, APEC and multilateral rule-making mechanisms, and actively encourage the participation of scientific research institutions, institutions of higher learning, industry associations and media, with the goal of moving closer to regulation, gradually achieve the international coordination of Chinese drug regulatory regulations, standards, technical guidelines and methods The General Administration consolidated and deepened the mechanism of bilateral cooperation between governments First of all, we should innovate ideas, work with relevant national food and drug regulatory agencies to create a comprehensive, centralized and close cooperation mode, establish China Denmark food and drug regulatory cooperation center, and implement bilateral cooperation projects Secondly, we are constantly improving the level and effectiveness of bilateral agreements We signed the agreement on the safety of drugs and medical devices with the U.S Department of health and human services; signed the memorandum on consultation and cooperation mechanism with the Ministry of health and health in Japan; signed the consultation and cooperation mechanism with the General Department of health and consumer protection of the European Union; signed the agreement on food Cooperation agreements in the fields of drugs, medical devices and cosmetics, which fix information exchange, regulatory exchange and communication mechanisms in the form of documents Third, focus on personnel exchanges, observation and inspection, generic drug review and other issues to share regulatory concepts and experience of various countries, and substantially promote bilateral cooperation The general administration actively carried out the introduction of international projects and capacity-building First of all, using the project funds provided by the World Health Organization, the Gates Foundation, the world bank, the global fund, the United Nations Industrial Development Organization, etc., to introduce international intellectual resources, strengthen their own capacity-building, and better serve the reform of China's drug review and approval system Secondly, give full play to the advantages of demonstration projects, select key industries in some regions as the pilot, learn from advanced experience, and build a comprehensive drug safety assurance system with Chinese characteristics Third, actively select personnel to participate in international conferences and projects, and serve in international organizations to strengthen cooperation and research in solving key technical problems The General Administration focuses on strengthening the international coordination capacity of major drug safety events First of all, relying on the existing information reporting system of the World Health Organization drug monitoring cooperation center and multi bilateral cooperation agreements, strengthen communication and exchange with relevant international organizations and regulatory agencies Secondly, we should improve the emergency plan for drug safety emergencies and foreign-related provisions, respond to domestic and international emergencies in a timely and effective manner, and realize information sharing In addition, we should strengthen cooperation with international organizations and regulatory agencies, take the initiative to intervene, communicate in time, follow up closely, and invite international experts to respond to public opinion Building BRICs cooperation mechanism In response to the results of this meeting, Yuan Lin expressed his expectation that the text of the BRICs memorandum of understanding on cooperation would be determined as soon as possible, consensus would be expanded, common ground would be sought, approval procedures would be completed as soon as possible, and the signing would be completed during the BRICs leaders' meeting, so as to formally establish the BRICs drug regulatory cooperation mechanism; he looked forward to establishing a smooth channel for exchange of laws and regulations, Regularly report the latest revision progress of laws and regulations, and regularly organize industry-oriented seminars to help relevant enterprises understand the regulatory and legal systems of various countries; encourage to build a cooperation platform for supervision and inspection, select excellent international inspectors on the basis of mutual observation and inspection, adopt internationally accepted inspection technical indicators, carry out joint inspection and achieve the corresponding inspection report Sharing; it is suggested to carry out pilot cooperation in the review of innovative drugs and generic drugs, with ICH technical guidelines as the core and relying on the pre certification system of the World Health Organization to explore the possibility of joint review; it is hoped that BRICs countries will coordinate, communicate their positions and respond to each other before and after major international multilateral conferences, and make a united voice on the stage of international rule making and revision, so as to expand the international voice 。
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