Medical network - on May 12, in order to further deepen the review for examination and approval system reform, promote the pharmaceutical medical equipment industry structure adjustment and technical innovation, improve the industrial competitiveness, meet the needs of the public clinical, the state food and drug administration and business departments concerned under the state council drafted the reform about medical equipment innovation encourage drugs clinical trial management policies "(draft), to solicit opinions from the public. The proposal will be sent by E-mail to the state administration of food and drug administration (pharmaceutical cosmetics registration administration) by May 25, 2017. The deadline for consultation is June 10, 2017. 

 

The contents of the proposed draft are related to the amended contents of the laws and regulations. 

 

E-mail: yhzcszhc@cfda.gov.cn 

 

I hereby announce that. 

 

Annex: relevant policies on encouraging the innovation of pharmaceutical medical devices innovation in clinical trial management (consultation) 

 

The general administration of food and drug administration 

 

On May 11, 2017 

 

The attachment 

 

Relevant policies on encouraging the innovation of pharmaceutical medical devices innovation in clinical trial management (draft) 

 

The qualification of a clinical trial organization shall be changed to the record administration. Disqualification of clinical trial institutions. Medical institutions with clinical trials and conditions may accept the application for clinical trials after the food and drug administration has designated the website for registration. We will encourage social capital investment to establish clinical trial institutions and provide professional services for clinical trials. The main clinical trial researchers should have senior titles and have participated in more than 3 clinical trials. The clinical trial applicant may hire a third party to evaluate the qualifications of the clinical trial organization. After the management of the clinical trial, the food and drug administration shall strengthen the on-site examination of the clinical trials and the results will be disclosed to the public. The data will not be accepted by the food and drug regulatory authorities for the clinical trials that failed to be examined. The regulation of clinical trial institutions shall be formulated by the food and drug administration in conjunction with the health and family planning department. 

 

Second, support researchers and clinical trial institutions to carry out clinical trials. Support the medical institutions, medical institutions, medical colleges and universities to participate in clinical trials, conditions and ability of clinical trials should be brought into the medical institutions rank evaluation, clinical key discipline of important indicators. We will encourage other medical institutions, such as tertiary institutions, and affiliated hospitals of higher undergraduate medical institutions, to undertake clinical trial work. For drug clinical trial of medical institutions to establish a separate evaluation system, the only used for conducting clinical trials of the bed is not included in the total hospital beds, medical institutions are not prescribed bed benefits, turnover, utilization evaluation index. We will encourage medical institutions to set up a professional clinical trial department and provide professional clinical trial personnel. We will encourage clinicians to participate in the innovative activities of pharmaceutical medical devices. Allow foreign enterprises and research institutes in China to carry out the drug Ⅰ phase of clinical trials. Medical personnel conducting clinical trials will treat clinicians equally in terms of job promotion and job promotion. In order to improve the income level of clinical trial researchers, we will improve the incentive mechanism of unit performance wage distribution. 

 

Third, improve the mechanism of ethics committees. Clinical trials must be in accordance with ethical and moral standards, to ensure the participants before the voluntary informed enough test information, understand and sign the informed consent, and to ensure the safety, health and rights and interests of the subjects are protected. Conducting clinical trials of medical institutions to establish ethics committee, is responsible for the review of the clinical testing scheme and make a decision of approval, request or not, is responsible for periodic review of clinical trials and real time supervision, check and accept the supervision department, responsible for the agency researchers qualification audit and supervision. Regions according to the need to set up a regional ethics committee, responsible for the examination and supervision of medical institutions to undertake clinical trial project and supervise the researchers' qualifications, try to appeal, the researchers and the applicant is responsible for the work of medical institutions ethics committee in the area of guidance. The ministry of health and family planning, the administration of traditional Chinese medicine and the food and drug administration should strengthen the management guidance and business supervision of the ethics committee. 

 

Fourth, improve the efficiency of ethical review. The applicant should submit the clinical trial plan to the ethics committee for examination and approval before applying for clinical trial application to the review organization. Multicenter clinical trial in China, the ethical review by the team leader and other members of the unit ethics committee can be recognized leader in the review conclusion, not repeat review. National center for clinical research and the national science and technology major projects and national key research and development plans to support the clinical test units, should integrate resources to establish a unified platform for ethical review, gradually promoting ethical review mutual recognition. 

 

Fifth, optimize the clinical trial review procedure. Establish and improve the communication and communication mechanism between the applicant and the appraisal organization. Carry out before drug clinical trial stage Ⅰ and Ⅲ communication must be approved by the applicant and the review meeting after formal applications and accepted. Prior to the clinical trial of medical devices for examination and approval, the applicant and the appraisal institution shall make formal application and acceptance after the meeting. Review mechanism of handling within 60 working days, did not give a negative or be deemed to have agreed to review opinion question, the applicant can be submitted in accordance with the plan to carry out clinical trials. During the clinical trials, clinical trial scheme changes, major pharmaceutical changes or non-clinical research and the safety issues, the applicant should submit the review bodies will change in time. In the case of safety and other risks, the applicant should revise the clinical trial plan, suspend or terminate the clinical trial in time. Review agencies shall strengthen supervision over the review of the clinical trial process, and organizations to make on-site verification to ongoing clinical trials, can organize the review process of clinical trial data for inspection. 

 

Data on clinical trials outside China. Outside the applicant in the clinical trial data, in conformity with the requirements of the relevant Chinese medicine medical device registration after on-site inspection can be used for filing an application for registration in China. Foreign enterprises in China international multicenter clinical drug trial, complying with the requirements of drug registration related, after completing the international multicenter clinical trial can directly apply for listing. In China for the first time, applicants should provide clinical trial data that do not have racial differences. Applicant drug administration in Europe, the United States and Japan approed generic bioequivalence test data, to meet the requirements of drug registration in China, after the on-site inspection can be used to declare generic drug registration in China. Applicant approed for sale in foreign medical apparatus and instruments, in addition to the need for clinical trials to the approval of the third class medical apparatus and instruments, outside submitted when an approed for clinical trial data, can be used as a clinical trial data are used to declare medical device registration in China. 

 

Supporting expanded clinical trials. For ongoing clinical trials for the treatment of severe life-threatening disease and there is no effective treatment of medical apparatus and instruments, the preliminary observation may benefit from clinical trials, and meet the requirements of the ethics, the informed consent can be used for other patients, after its safety data can be used to support review of the examination and approval. Expand the use of experimental drugs, only in conducting Ⅱ, Ⅲ period clinical trial institution to use, using a number of clinical trials may not exceed the stipulated number of subjects.