Food and Drug Administration： Falsification and fabrication of data in clinical trials will be severely punished

　　BEIJING, Oct. 9 (Xinhua)-Talking about the reform of clinical trial management, Wang Zhexiong, director of the china food and drug administration Medical Device Registration Department, said today that he will jointly introduce the filing conditions and filing management measures for clinical trial institutions with the National Health and Family Planning Commission, establish a filing management information system for clinical trial institutions and clinical trial projects, strengthen supervision and inspection, and severely investigate and punish illegal acts of practicing fraud and fabricating clinical trial data during clinical trials.

　　On October 8th, the General Offices of the General Office of the Central Committee of the CPC and the State Council issued the Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Medicines and Medical Devices, with a total of 36 articles in six parts. China food and drug administration held a press conference today to introduce the reform of drug and medical device examination and approval and encourage innovation, and to answer questions from reporters.

　　Wang Xiongxiong said that in 2014, the Food and Drug Administration issued the "Special Approval Procedure for Innovative Medical Devices (Trial)", which included innovative products with China’s invention patents, independent intellectual property rights, domestic pioneering technology, international leading level and significant clinical application value in special approval channels. At present, 29 products have been approved for marketing.

　　In 2016, the Food and Drug Administration issued the Priority Approval Procedure for Medical Devices, which included the products listed in the national major projects or key research and development plans, including the treatment of rare diseases, malignant tumors, diseases unique to the elderly and frequent diseases, including children’s special medical devices into the priority approval procedure. At present, eight products have been included in the priority approval scope. By innovating the special examination and approval of medical devices and giving priority to the examination and approval of medical devices, the trauma of operation is reduced, the diagnosis and treatment needs of special patients are met, the probability of early detection of diseases is improved, and the timely treatment of patients in the later period is ensured. The listing of these products provides clinicians with choices, reduces clinical costs through the supply of products, and makes patients feel the benefits of reform.

　　This time, the Central Office and the State Council issued opinions on deepening reform and encouraging innovation, and will carry out the following work in the reform of medical device review and approval.

　　The first is to reform the management of clinical trials.The filing conditions and filing management measures of clinical trial institutions will be jointly promulgated with the National Health and Family Planning Commission, the filing management information system of clinical trial institutions and clinical trial projects of medical devices will be established, and the supervision and inspection of clinical trial institutions and clinical trial projects will be strengthened. Illegal acts of practicing fraud and fabricating clinical trial data during clinical trials will be severely investigated and punished according to law.

　　For medical devices that are seriously life-threatening and have no effective treatment methods, the initial observation in clinical trials may benefit, allowing them to be used by other patients after informed consent through extended clinical trials, and the corresponding data can be used for the registration application of medical devices. At the same time, the clinical trial review and approval of medical devices will be changed from express permission to implied permission to improve efficiency.

　　The second is to speed up the review and approval of medical devices listed.Receive overseas clinical trial data that meet the requirements of China’s medical device registration regulations when registering medical devices, and at the same time, scientifically and reasonably set relevant requirements for clinical evaluation of medical devices, speed up the examination and approval of medical devices that are urgently needed in clinic, and reduce clinical trials for medical devices with rare diseases, and grant conditional approval for listing. There is no effective treatment for diseases that seriously endanger life, and medical devices that are urgently needed in public health can also be approved for marketing with conditions attached. Priority will continue to be given to the review and approval of innovative medical devices supported by major national science and technology projects and key national R&D plans.

　　The third is to improve the examination and approval system of medical devices and strengthen the capacity building of medical device evaluation institutions.Form a new review and approval system with review as the leading factor and inspection, testing and evaluation as the support. Carry out team review, establish a project review team composed of reviewers from clinical medicine, clinical diagnosis, machinery, electronics, materials and biomedical engineering, and be responsible for the review of innovative products.

　　Constantly improve the communication mechanism between registered applicants and the evaluation center, strictly implement the expert advisory Committee system, and demonstrate major technical issues by the expert advisory Committee. We will promote the registration and evaluation of medical devices to be included in the pilot scope of government-purchased services. Through this measure, we will increase the number of reviewers and expand the team of reviewers. At the same time, we will strengthen the training of reviewers, improve their quality and establish a professional team of reviewers. The documents of the two offices also mentioned that it is necessary to actively promote the unification of the evaluation standards for Class II medical devices and gradually realize the unified national evaluation.

　　Fourth, implement the life cycle management of medical devices, strengthen the construction of inspectors, gradually establish a professional inspector team, strengthen the training of inspectors, and improve the ability and level of inspectors.Strengthen the supervision and inspection of the implementation of quality management standards for clinical trials and production quality management standards for medical devices. In this process, we should gradually improve the system of medical device registrants, and implement the legal responsibilities of registrants in the whole process and life cycle of medical device design and development, clinical trials, manufacturing, sales and distribution, product recall, adverse event reporting and re-evaluation.

　　Wang Xiongxiong said that through the above measures, medical device innovation will be further encouraged to meet the needs of clinical use, stimulate the development vitality of China’s medical device industry, and promote the healthy and rapid development of China’s medical device industry.