Notice of the General Administration of the people's Republic of China on Soliciting Opinions on relevant policies on encouraging innovation and reform of clinical trial management of pharmaceutical and medical devices (Draft for comments) (No. 53, 2017)

Source: CFDA 2017-05-12 In order to further deepen the reform of the review and approval system, promote the adjustment of the industrial structure and technological innovation of pharmaceutical and medical devices, improve the industrial competitiveness, and meet the clinical needs of the public, the State Food and drug administration, in consultation with the relevant departments of the State Council, drafted the relevant policies on encouraging the innovation and reform of clinical trial management of pharmaceutical and medical devices (Draft for comments), which are now open to the public Ask for advice It is suggested that the modification opinions be fed back to the State Food and Drug Administration (drug and cosmetic registration administration department) by email before May 25, 2017 The deadline for consultation is June 10, 2017 The amendment of laws and regulations in the draft shall be carried out according to relevant procedures Email: yhzcszhc@cfda.gov.cn is hereby announced Annex: relevant policies on encouraging innovation and reform of clinical trial management of pharmaceutical and medical devices (Draft for comments) annex of food and Drug Administration on May 11, 2017 on encouraging innovation and reform of clinical trial management of pharmaceutical and medical devices (Draft for comments) I The qualification of clinical trial institutions is changed to record management Disqualification of clinical trial institutions After being registered on the website designated by the food and drug administration, the medical institutions with clinical trial conditions can accept the entrustment of the applicant to carry out clinical trials We will encourage social capital to invest in the establishment of clinical trial institutions and provide professional services for clinical trials The main researchers of clinical trials shall have senior titles and have participated in more than 3 clinical trials The clinical trial applicant may employ a third party to evaluate and certify whether the clinical trial institution is qualified After the clinical trial institutions implement the filing management, the food and drug regulatory authorities shall strengthen the on-site inspection of the clinical trial items, and the inspection results shall be open to the public If the clinical trial fails to pass the examination, the relevant data will not be accepted by the food and drug regulatory authorities The administrative provisions for clinical trial institutions shall be formulated by the food and drug regulatory department together with the health and family planning department 2、 Support researchers and clinical trial institutions to carry out clinical trials We will support medical institutions, medical research institutions and medical colleges and universities to participate in clinical trials, and bring the conditions and capabilities of clinical trials into the important indicators of medical institutions' level evaluation and clinical key disciplines identification We will encourage the affiliated hospitals of the third class a medical institutions and provincial medical colleges and universities to undertake clinical trials A separate evaluation and assessment system shall be established for medical institutions carrying out drug clinical trials The beds only used for clinical trials shall not be included in the total beds of medical institutions, and evaluation indexes such as bed efficiency, turnover rate and utilization rate shall not be specified Medical institutions are encouraged to set up full-time clinical trial departments with professional clinical trial personnel Encourage clinicians to participate in technical innovation activities of medical devices Overseas enterprises and scientific research institutions are allowed to carry out phase I clinical trials of drugs in China The medical staff who carried out clinical trials were treated equally with the clinicians in terms of post promotion and professional title promotion In combination with the improvement of the incentive mechanism of performance-based salary distribution, to ensure the income level of clinical trial researchers 3、 Improve the mechanism of ethics committee The clinical trial shall conform to the ethical standards, ensure that the subjects are informed of sufficient trial information before voluntary participation, understand and sign the informed consent, and ensure that the safety, health and rights of the subjects are protected Medical institutions conducting clinical trials shall establish an ethics committee to review the clinical trial scheme and make decisions on approval, modification or disapproval, conduct regular review and real-time supervision of clinical trials and accept the inspection of regulatory authorities, and be responsible for the review and supervision of the qualification of researchers in their own institutions Each region may establish a regional ethics committee according to its needs, which is responsible for reviewing and supervising the clinical trial projects undertaken by medical institutions and supervising the qualifications of researchers, hearing the appeals of researchers and applicants, and guiding the work of the ethics committee of medical institutions in the region Health and family planning departments, traditional Chinese medicine management departments and food and drug regulatory departments should strengthen the management guidance and business supervision of the work of the ethics committee 4、 Improve the efficiency of ethical review The applicant shall submit the clinical trial scheme to the Ethics Committee for examination and approval before submitting the application for clinical trial to the review institution If a multi center clinical trial is carried out in China, the ethics committee of other member units may approve the review conclusion of the leader unit after the ethical review of the leader unit, and no more review will be repeated National medical clinical research center and clinical trial institutions supported by major national science and technology projects and national key R & D plans should integrate resources to establish a unified platform for ethical review and gradually promote mutual recognition of ethical review 5、 Optimize clinical trial review procedures Establish and improve the communication and exchange mechanism between the applicant and the review institution Before carrying out phase I and phase III drug clinical trials, formal application and acceptance shall be conducted after communication between the applicant and the review institution Before carrying out the clinical trial of the medical device to be approved, the applicant shall formally apply for and accept it after communicating with the review institution After 60 working days from the date of acceptance, the review institution shall be deemed to agree if it does not give a negative or questioned review opinion, and the applicant can carry out the clinical trial according to the submitted scheme During the clinical trial, in case of any change of clinical trial scheme, major pharmaceutical change or non clinical research safety problem, the applicant shall timely submit the change to the review institution If safety and other risks are found, the applicant shall timely modify the clinical trial scheme, suspend or terminate the clinical trial The review organization shall strengthen the review and supervision of the whole process of the clinical trial, organize on-site verification of the ongoing clinical trial, and organize the causal inspection of the clinical trial data during the review process 6、 Accept the data of overseas clinical trials If the clinical trial data obtained by the applicant abroad meet the relevant requirements of China's drug and medical device registration, it can be used to apply for registration in China after on-site inspection If the international multi center clinical trials conducted by overseas enterprises in China meet the relevant requirements of Chinese drug registration, they can directly apply for listing after completing the international multi center clinical trials For the first time to apply for listing of medical devices in China, the applicant shall provide clinical trial data without racial differences If the bioequivalence test data of the applicant's generic drugs approved for marketing in the European drug administration, the United States and Japan meet the relevant requirements of Chinese drug registration, it can be used to apply for generic drug registration in China after on-site inspection For the medical devices approved for listing abroad, in addition to the class III medical devices that need to be approved for clinical trials, the clinical trial data submitted when approved for listing abroad can be used as clinical trial data for applying for registration of medical devices in China 7、 Support extended clinical trials For the medical devices that are in clinical trials to treat diseases that are seriously life-threatening and have no effective treatment means, they may benefit from the preliminary observation of clinical trials and meet the ethical requirements, they can be used for other patients with informed consent, and their safety data can be used to support the review and approval The extended use of test drugs is limited to the institutions conducting phase II and phase III clinical trials, and the number of users shall not exceed the number of subjects specified in the clinical trials.