Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices

Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices
Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices

October 8, 2017

In view of the rapid development of drugs and medical devices industry, as well as the ascendant innovation and entrepreneurship in China at present, the reform of the evaluation and approval continues. However, since the support to scientific and technological innovation of drugs and medical devices is not enough on the whole, there is a gap between the quality of products on the market and the quality of those internationally advanced products. In order to promote the structural adjustment to and technical innovations of drugs and medical devices, improve the industrial competitiveness, and satisfy the clinical needs of the public, the following opinions on deepening the reform of the evaluation and approval system and inspiring innovation of drugs and medical devices are hereby presented.

I. Reform of the Clinical Trials Management
(I) The accreditation of the institutions for clinical trials shall be subject to record-filing administration. The institutions with clinical trial conditions may be entrusted by applicants for registration of drugs or medical devices to carry out clinical trials, after they have registered and filed a record on the website designated by the food and drug regulators. The main clinical trial researchers shall have senior titles and have participated in three or more clinical trials. The applicant for registration may appoint a third party to evaluate and verify the qualifications of the clinical trial institution. Private investors are encouraged to set up clinical trial institutions. The provisions on the administration of clinical trial institutions shall be formulated by the China Food and Drug Administration ("CFDA") in concert with the National Health and Family Planning Commission ("NHFPC").
(II) Clinical trial institutions and researchers shall be supported to carry out clinical trials. Medical institutions, medical research institutions, medical colleges and universities shall be supported to carry out clinical trials and the clinical trial conditions and competency evaluation shall be included in the evaluation of ranking of medical institutions. The medical institutions that carry out clinical trials shall be subject to a separate evaluation and appraisal system. The hospital beds used in clinical trials shall not be included in the total number of beds of the medical institutions, and the evaluation indexes such as the efficiency of the beds, the rate of turnover and the utilization rate will not be specified. Medical institutions shall be encouraged to set up departments dedicated to clinical trials, and such departments should be equipped with professional clinical trial researchers. The incentive and allocation mechanism for the performance-based pay of an institution shall be perfected to ensure the level of income received by clinical trial researchers. Clinicians shall be encouraged to participate in the technical innovation activities of drugs and medical devices, and clinic trial researchers shall be treated in an equitable manner with the clinicians, in respect of promotion and professional title promotion. Foreign enterprises and scientific research institutions shall be allowed to carry out clinical trials of new drugs simultaneously in China in accordance with the law.
(III) The ethics committee mechanism shall be improved. Clinical trials shall comply with ethical standards to ensure that subjects are informed of sufficient information on trials before their voluntary participation, understand and sign informed consent form, and to protect the safety, health and interests of the subjects. The clinical trial institutions shall set up an ethics committee to review their clinical trial programs, review and supervise the qualification of clinical trial researchers, supervise the development of clinical trials and be inspected by regulators. The regional ethics committees may be set up by local departments to guide the ethical review of clinical trial institutions, conduct the ethnic review of clinical trial program as entrusted by institutions and applicants for registration not eligible for ethnic review and supervise the development of clinical trials. The health and family planning authority, Chinese medicine administration, food and drug administration and other authorities shall strengthen the management of, guidance on and supervision over the work done by the ethics committees.
(IV) The efficiency of ethnics review shall be enhanced. Before an application for clinical trial is filed by the applicant for registration, the clinical trial program shall be submitted to the ethics committee of the clinical trial institution for evaluation and approval. If clinical trials are carried out in a number of centers in China, after the ethical evaluation by the leading unit of the clinical trial, other member units shall recognize the conclusion of such evaluation and no additional evaluation may be carried out for avoidance of repeat. The national clinical research centers and clinical trial institutions undertaking major national science and technology projects and projects supported by key national research and development plans shall integrate resources to build a unified platform, to gradually promote the mutual recognition of ethical review.
(V) The approval procedures for clinical trials shall be optimized. A mechanism for communications and exchange between applicants for registration and evaluation entities shall be established and improved. Before the acceptance of the drug clinical trials and the evaluation of the clinical trials of medical devices for approval, the evaluation entities shall communicate with the applicant for registration and offer advices and suggestions. Within a period after the acceptance of the clinical trial application, such application shall be deemed approved if no negative opinion or question is presented by food and drug regulator, and the applicant for registration may carry out the clinical trial in accordance with the program submitted. In the event of any change in the clinical trial program, significant pharmaceutical change or non-clinical research safety issue during clinical trials, the applicant for registration shall submit such change to evaluation entity in a timely manner, and shall modify the clinical trial program or otherwise suspend or terminate the clinical trial in a timely manner, if any safety risk or other risk is found out. The applicant for drug registration may issue a report on inspection of clinical trial samples or entrust an inspection body to do so, submit such report and the samples to drug evaluation entity and ensure that the samples actually used in clinic trials are as same as those submitted. The procedures of evaluation and approval of activities for human genetic resources, involved with international cooperation, shall be optimized to shorten the process of clinical trials.
(VI) The data from foreign clinical trials shall be accepted.