Human genetic resources administrative punishment announced: AstraZeneca and other institutions listed!

The following is the full text of six administrative punishments: letter of decision on administrative punishments (gkj [2018] No.1) Company Name: AstraZeneca investment (China) Co., Ltd address: No.199, Liangjing Road, China (Shanghai) pilot Free Trade Zone legal representative: Feng Ji According to the Interim Measures for the management of human genetic resources (GBF [1998] No 36), the administrative punishment law of the people's Republic of China and other relevant provisions, China human genetic resources management office has investigated the case of AstraZeneca investment (China) Co., Ltd (hereinafter referred to as "AstraZeneca") violating the provisions on the management of human genetic resources, and the investigation has been completed It is found that the following illegal behaviors exist AstraZeneca transferred the remaining samples of the approved projects to Xiamen Eide Biomedical Technology Co., Ltd and kunhaoruicheng pharmaceutical R & D (Beijing) Co., Ltd without permission to carry out scientific research activities beyond the scope of approval The above acts violate the provisions of Article 4 and Article 11 of the Interim Measures for the management of human genetic resources In accordance with Article 22 of the Interim Measures for the management of human genetic resources, the administrative license law of the people's Republic of China and the administrative penalty law of the people's Republic of China, the punishment is hereby decided as follows: 1 Give a warning to AstraZeneca 2 Confiscate and destroy the materials of human genetic resources illegally used 3 Two administrative licenses (gkhbsz [2015] No 83 and [2016] No 837) were revoked 4 From the date of service of this decision, the application of AstraZeneca for international cooperation activities involving human genetic resources in China shall be stopped, and the application shall be accepted after the rectification and acceptance are qualified According to Article 32 of the administrative punishment law of the people's Republic of China, if your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this administrative punishment decision, or file an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of administrative reconsideration and administrative litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Decision on administrative penalty issued by the Ministry of science and technology on July 12, 2018 gkj [2018] No.2 Unit Name: Xiamen Eide Biomedical Technology Co., Ltd address: No.39 Dingshan Road, Haicang District, Xiamen legal representative: li-mouzheng According to the Interim Measures for the management of human genetic resources (GBF [1998] No 36), the administrative punishment law of the people's Republic of China and other relevant provisions, the human genetic resources management office of China has investigated the case of Xiamen Eide Biomedical Technology Co., Ltd (hereinafter referred to as "Xiamen Eide") in violation of the provisions on the management of human genetic resources, and the investigation has been completed It is found that the following illegal behaviors exist Xiamen Eide has received 30 tubes of samples from AstraZeneca investment (China) Co., Ltd without permission, which are intended to be used in the activities related to the development of kits The above acts violate the provisions of Article 4 and Article 11 of the Interim Measures for the management of human genetic resources According to the relevant provisions of the administrative punishment law of the people's Republic of China and the Interim Measures for the management of human genetic resources, the punishment was decided as follows: 1 Xiamen Eide was warned 2 Confiscate and destroy the materials of human genetic resources illegally used According to Article 32 of the administrative punishment law of the people's Republic of China, if your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this administrative punishment decision, or file an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of administrative reconsideration and administrative litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Decision of administrative penalty issued by the Ministry of science and technology on July 12, 2018 No.3 Unit Name: kunhao Ruicheng pharmaceutical research and development (Beijing) Co., Ltd address: Room 302, building 15, yard 8, Liangshuihe 2nd Street, Beijing Economic and Technological Development Zone legal representative: Zhang Yan According to the Interim Measures for the management of human genetic resources (GBF [1998] No 36), the administrative punishment law of the people's Republic of China and other relevant provisions, the human genetic resources management office of China has investigated the case of kunhaoruicheng pharmaceutical research and development (Beijing) Co., Ltd (hereinafter referred to as "kunhaoruicheng") violating the provisions on the management of human genetic resources, and the investigation has been completed It is found that the following illegal behaviors exist: Kun haoruicheng received 567 samples of AstraZeneca investment (China) Co., Ltd without permission and kept them The above acts violate the provisions of Article 4 and Article 11 of the Interim Measures for the management of human genetic resources According to the relevant provisions of the administrative punishment law of the people's Republic of China and the Interim Measures for the management of human genetic resources, the punishment is decided as follows: 1 Warn kunhaoruicheng 2 Confiscate and destroy the materials of human genetic resources illegally used According to Article 32 of the administrative punishment law of the people's Republic of China, if your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this punishment decision, or bring an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of reconsideration and litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Decision on administrative penalty issued by the Ministry of science and technology of the people's Republic of China on July 31, 2018 gkj [2016] No.1 Unit Name: Suzhou yaomingkant new drug development Co., Ltd address: no.1318, Wuzhong Avenue, Wuzhong District, Suzhou legal representative: Li Ge According to the Interim Measures for the management of human genetic resources (GBF [1998] No 36), the administrative punishment law of the people's Republic of China and other relevant provisions, the China human genetic resources management office has investigated the case of Suzhou yaomingkant new drug development Co., Ltd (hereinafter referred to as Suzhou yaomingkant company) suspected of violating the provisions on the management of human genetic resources, which has been investigated The end It has been found that the following illegal behaviors exist: Suzhou Pharmaceutical Co., Ltd illegally exported 5165 human genetic resources (human serum) as dog plasma without permission The above behaviors violate the provisions of Article 4 and Article 16 of the Interim Measures for the management of human genetic resources In accordance with Article 21 of the Interim Measures for the management of human genetic resources and the relevant provisions of the administrative punishment law of the people's Republic of China, the punishment is hereby decided as follows: 1 Give a warning to Suzhou yaomingkant company 2 Confiscate and destroy the human genetic resources materials in the project 3 Since the date of service of this decision, the Ministry of science and technology has suspended the acceptance of the application of Suzhou yaomingkant Co., Ltd for international cooperation and outbound activities related to human genetic resources in China, and will resume the application after the rectification and acceptance are qualified According to Article 32 of the administrative punishment law of the people's Republic of China, if your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this administrative punishment decision, or file an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of reconsideration and litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Decision on administrative penalty issued by the Ministry of science and technology of the people's Republic of China on October 21, 2016 gkj [2015] No 1 unit name: Huashan Hospital Affiliated to Fudan University Address: No 12, middle Urumqi Road, Shanghai legal representative: Ding Qiang According to the Interim Measures for the management of human genetic resources (GBF [1998] No.36), the administrative punishment law of the people's Republic of China and other relevant provisions, the international "large sample case control study on Chinese female unipolar depression" carried out by China Human Genetic Resources Management Office (hereinafter referred to as GBO) on Huashan Hospital Affiliated to Fudan University (hereinafter referred to as Huashan Hospital) The investigation of scientific research cooperation has been carried out and has now been completed It is found that the following illegal behaviors exist: Huashan Hospital and Shenzhen Huada Gene Technology Service Co., Ltd carry out international cooperation research on human genetic resources in China with Oxford University without permission, and Huashan Hospital transmits part of human genetic resources information from the Internet without permission The above acts violate the provisions of Article 4, Article 11 and Article 16 of the Interim Measures for the management of human genetic resources In accordance with Article 21 of the Interim Measures for the management of human genetic resources and the relevant provisions of the administrative punishment law of the people's Republic of China, the punishment is hereby decided as follows: 1 Your unit shall immediately stop the implementation of the research work from the date of receiving this decision 2 Destroy all genetic resource materials and relevant research data not leaving the country in the research work 3 The international cooperation of Huashan Hospital involving human genetic resources in China shall be stopped from the date of service of this decision, and shall be carried out after the rectification and acceptance are qualified If your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this administrative punishment decision, or bring an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of reconsideration and litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Decision on administrative penalty issued by the Ministry of science and technology of the people's Republic of China on September 7, 2015 gkj [2015] No 2 unit name: Shenzhen Huada Gene Technology Service Co., Ltd address: comprehensive building, Beishan Industrial Zone, Yantian District, Shenzhen City, Guangdong Province legal representative: Liu Na According to the Interim Measures for the management of human genetic resources (GBF [1998] No.36), the administrative punishment law of the people's Republic of China and other relevant provisions, the China Human Genetic Resources Management Office (hereinafter referred to as the genetic Office) carried out a large sample case-control study on Chinese female unipolar depression in Shenzhen Huada Gene Technology Service Co., Ltd (hereinafter referred to as Huada Technology) ”The international cooperation in scientific research has been investigated, and the investigation has now ended It is found that the following illegal behaviors exist: Huada technology and Huashan Hospital carry out international cooperation research on human genetic resources in China with Oxford University without permission, and Huada technology transmits part of human genetic resources information from the Internet out of the country without permission The above acts violate the provisions of Article 4, Article 11 and Article 16 of the Interim Measures for the management of human genetic resources In accordance with Article 21 of the Interim Measures for the management of human genetic resources and the relevant provisions of the administrative punishment law of the people's Republic of China, the punishment is hereby decided as follows: 1 Your unit shall immediately stop the implementation of the research work from the date of receiving this decision 2 Destroy all genetic resource materials and relevant research data not leaving the country in the research work 3 The international cooperation of Huada science and technology involving human genetic resources in China shall be stopped from the date of service of this decision, and shall be carried out after the rectification and acceptance are qualified If your unit refuses to accept this punishment decision, it can apply for administrative reconsideration to the Ministry of science and technology within 60 days from the date of receiving this administrative punishment decision, or bring an administrative lawsuit to the people's court with jurisdiction within 6 months This decision shall not be suspended during the period of reconsideration and litigation If the decision is not fulfilled within the time limit, the penalty organ shall apply to the people's court for compulsory execution Ministry of science and technology of the people's Republic of China September 7, 2015