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On July 1st, the Regulations of the People's Republic of China on the Administration of Human Genetic Resources came into effect, which is not the first regulation on the management of human genetic resources in China, but it is regulated and strengthened against the background of rapid advances in biotechnology.
the Ministry of Justice, the Ministry of Science and Technology on the "People's Republic of China Regulations on the Administration of Human Genetic Resources" in response to a reporter, said that the "People's Republic of China Regulations on the Administration of Human Genetic Resources" focused on the protection of China's human genetic resources, promote the rational use of human genetic resources, from the source to prevent illegal access to human genetic resources for biotechnology research and development activities.
", with the development of the situation, there are some new situations and problems in the management of human genetic resources in China, the illegal outflow of human genetic resources is constantly occurring, the use of human genetic resources is not standardized, lack of overall planning, the relevant system of international cooperation and scientific research using human genetic resources is not perfect, the provisional measures also exist the lack of regulation of the use of human genetic resources, legal liability is not complete, regulatory measures need to be further improved.
"related response.
biomedical big data to the national strategic resources of human genetic resources including human genetic resources materials and human genetic resources information; Jin Li, a member of the Chinese Academy of Sciences and vice president of Fudan University, said that information on human genetic resources, like the "life statement" of human beings, is a genetic material or information that can be used individually or jointly to identify human characteristics, is an important material and information basis for life science research, is the basic information for cognition and mastering the law of disease occurrence, development and distribution, is an important guarantee to promote the development of disease prevention, intervention and control strategies, and has become a strategic, public welfare and basic resource for public health and life safety.
"We are moving towards the age of precision medicine, and the directions of targeted drugs, biotherapy, histological technology, big data, molecular diagnostics, and molecular imaging are booming,"
.
the development of precision medicine needs to build the corresponding support system and platform, of which human genetic resources is the cornerstone of precision medical research.
the Regulations of the People's Republic of China on the Administration of Human Genetic Resources to encourage the rational exploitation and utilization of human genetic resources in China will provide a strong legal guarantee for China to achieve the goal of a biotechnology power.
" said Zhan Qimin, a member of the Chinese Academy of Engineering and vice-president of Peking University.
the publication of the Regulations of the People's Republic of China on the Administration of Human Genetic Resources, Zhao Guoping, a member of the Chinese Academy of Sciences and former vice president of the Shanghai Institute of Life Sciences of the Chinese Academy of Sciences, said that over the past two decades, "genomics" technology has advanced rapidly, opening up the data-intensive paradigm of life science research, and the biomedical "big data" with human genetic and epitopitual data as the core has become a strategic and basic resource for countries, societies and peoples as important as human genetic resources.
but due to the natural attributes of biomedical big data with the innate "multi-scale, high-dimensional, heterogeneous, complex system", as well as social attributes such as the allocation of rights and privacy security and other social attributes formed by the social development level constraints in the use of data, biomedical data is often burdened by the difficulties of standardized quality control and integration and sharing, and there is a serious problem of "data big" rather than "big data".
now, the Regulations of the People's Republic of China on the Administration of Human Genetic Resources clearly stipulate that "the State encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to carry out the preservation of human genetic resources in accordance with their own conditions and the needs of relevant research and development activities, and facilitates other units to carry out relevant research and development activities".
, therefore, Zhao Guoping suggested that it is urgent to establish a unified authoritative data technology engineering platform, gather a group of technical personnel and engineering team engaged in data research and development and services, long-term, dedicated to the integration of data accumulation, to provide data sharing and utilization of public welfare services.
solve new problems in the management of human genetic resources Last October, the official website of the Ministry of Science and Technology published six tickets, Huada Gene, AstraZeneca, Medicine Mingkang, Shanghai Huashan Hospital and other six companies or institutions were punished by the Ministry of Science and Technology for violating the regulations on the management of human genetic resources.
penalties are 2015, 2016 and 2018 respectively, but the reasons for the punishment are violations by the relevant companies or institutions in violation of the Interim Measures for the Administration of Human Genetic Resources (No. 36 of the State Administration (1998), the Administrative Punishment Law of the People's Republic of China, and other relevant provisions, illegal collection, collection, sale, export, export of human genetic resources.
it is understood that this is the first time that the Ministry of Science and Technology has publicly involved human genetic resources administrative penalties.
reported that the three tickets in 2018 involved three enterprises involved, but also for "conducting scientific research activities beyond the scope of approval", in which AstraZeneca without permission to the approved project of the remaining samples transferred to Xiamen Eide Biopharmaceutical Technology Co., Ltd. and Kun Yurui Prudential Pharmaceutical Research and Development (Beijing) Co., Ltd., to carry out research activities beyond the scope of approval.
Xiamen Eide received 30 tubes of AstraZeneca without permission for use in kit development-related activities.
received and kept a sample of AstraZeneca 567 tubes without permission.
fines show that three companies were warned by regulations to confiscate and destroy materials from human genetic resources that were used in violation of the law.
the Interim Measures for the Administration of Human Genetic Resources, which was based on the penalty at that time, is the main legal basis for the protection of human genetic resources before the implementation of the Regulations of the People's Republic of China on Human Genetic Resources, Jin Li pointed out that, because of the importance of human genetic resources, China's well-known geneticist Mr. Jiaxuan in 1997 called for the protection of China's genetic resources, successfully promoted the development of China's genome research, and promoted the national human genome north and south center in 1998, the formal establishment of the Interim Measures for the Administration of Human Genetic Resources.
but Zhan Qimin believes that in the past certain period of time, we have insufficient rational development and utilization of human genetic resources, insufficient effective protection, and inadequate sharing mechanism.
therefore, "With the development of the situation, in order to solve the new situation and problems facing China's human genetic resources management practice, it is very necessary to formulate the Regulations of the People's Republic of China on the Administration of Human Genetic Resources on the basis of summing up the experience of the implementation of the provisional measures. Jin Li stressed. Cao Lei, an associate professor at Min University Law School Chinese
to strengthen regulation of life science research, said the regulations are an efficient document adapted to the needs of reality and a regulation that raises the importance of human genetic resources to a national security perspective.
she suggested whether, with the sensitivity and importance of human genetic resources, whether their protection and norms should be further raised to the legal level, clearly in the form of legal provisions, and stronger coercive measures in the future in dealing with relevant cases.
", from the previous case of the penalty, if still stay in the administrative regulations, compared to the harm, the corresponding punishment is relatively light.
" genomics experts interviewed by Science and Technology Daily said that although the Regulations of the People's Republic of China on the Administration of Human Genetic Resources have been implemented, the working rules of concern have not yet come out.
, Cao Lei also said that the "People's Republic of China Regulations on the Management of Human Genetic Resources" is adapted to the reality of the introduction, but this is only the first step, in the future with the new situation will continue to be revised and perfected.
" For example, in the view of the legal profession, some of these concepts need to be further clarified and regulated, such as blood and information, which belong to human genetic resources, but the legal status of information is 'things' or 'non-things', is a controversial issue.
," Cao said.
in addition, the scope of protection as defined in the Regulations of the People's Republic of China on the Administration of Human Genetic Resources includes materials of human genetic resources and information materials on human genetic resources, but there are great differences between the former and the latter in external forms, storage means, means of transport, etc., especially with the improvement of the level of information, the past way of human flesh has been replaced by more diversified technical means, the normative use of materials and restrictions on exit bring suscapless risks, but also to the definition of management responsibility and the division of tort liability.
reported that, in order to further strengthen the regulation and supervision of life science research and medical activities, including "gene editing", the State Council will also speed up the legislative work this year on the management of safety management of biotechnology research and development and the clinical application of new biomedical technologies, and form the whole process of supervision chain together with the Regulations of the People's Republic of China on the Administration of Human Genetic Resources. Cao Lei,
, said that biotechnology is very new, change is also very fast, it is difficult to simply summarize the step-by-step violation of fetal rights exposed in the case of geneticed editing infants, the right to know and privacy rights of the parents involved, the administration of the non-standard ethics committee, etc., are in the academic community to trigger extensive discussion of the issue, but also the future legislative work needs to pay attention to and refine the node.
Source: Science Daily.