Announcement of the State Food and Drug Administration and the National Health Commission on the rel
Announcement of the State Food and Drug Administration and the National Health Commission on the release of the "Provisions on the Administration of Medical Device Expanded Clinical Trials (Trial)"
In order to implement the Opinions of the General Office of the Central Committee of the Communist Party of China and The General Office of the State Council on Deepening the Reform of the Review and Approval System to Encourage Innovation of Pharmaceutical and Medical Devices, and support the work of Extended clinical trials of Medical devices, the State Medical Products Administration and the National Health Commission have formulated the Provisions on the Administration of Extended Clinical Trials of Medical Devices (Trial), which are hereby issued.
Annex: Regulations on the Management of Extended Clinical Trials for Medical Devices (Trial)
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Regulations on the Administration of Extended Clinical Trials for Medical Devices (Trial)
Chapter I General rules
Article 1 In order to meet the clinical needs of the public, enable patients in urgent need of clinical treatment to obtain experimental medical devices as soon as possible, regulate the development of extended clinical trials of medical devices and the collection of safety data, and safeguard the rights and interests of subjects, according to the General Office of the Communist Party of China Central Committee and The General Office of the State Council "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices", Formulate these provisions.
Article 2 These Provisions shall be observed in conducting extended clinical trials of medical devices within the territory of the People's Republic of China.
Article 3 The term "extended clinical trials of medical devices" as mentioned in these Provisions refers to the activities and processes in which patients suffering from life-threatening diseases without effective treatment can use medical devices that have not yet been approved for market in the institutions conducting clinical trials.
The use of medical devices for extended clinical trials should be based on the possibility that the initial observation of existing clinical trials may benefit the patients, and the patients cannot obtain the use of the medical devices by participating in existing clinical trials because the clinical trial institution has completed the inclusion of cases according to the clinical trial protocol.
Article 4 Extended clinical trials of medical devices shall comply with the relevant provisions of clinical trial quality management of medical devices.
Chapter II Rights and Responsibilities
Article 5 Extended clinical trials of medical devices shall follow the ethical guidelines established by the Declaration of Helsinki of the World Medical Congress to protect the rights and interests of subjects.
Before the subjects participate in the extended clinical trial, the subjects and researchers should sign the informed consent in accordance with the requirements of the Medical Device Clinical Trial Quality Management Practice. Informed consent should ensure that subjects understand that they will be treated with the investigational medical device, clearly inform subjects that the medical device used in the extended clinical trial has not been authorized for marketing in the country, and that the investigational medical device may have risks regarding safety and efficacy. The subject's participation in the extended clinical trial of medical device should be voluntary, and the subject has the right to withdraw from the trial at any time during the trial.
In the ethical review, the rights and interests of the subjects should be fully protected, based on the potential risks of the extended use of medical devices, considering the course of the disease, and confirming that the benefits of the subjects outweigh the risks.
Article 6 The subjects, researchers, sponsors and clinical trial institutions conducting extended clinical trials of medical devices shall sign agreements to clarify the rights, obligations and responsibilities of each party. Sponsors, investigators, clinical trial institutions and ethics committees shall assume their respective responsibilities in accordance with the requirements of the Medical Device Clinical Trial Quality Management Practice.
Medical device clinical trial institutions in the establishment of medical device clinical trial quality management system, in order to effectively control the quality and risk of medical device extended clinical trial, should be based on the characteristics of extended clinical trial to increase the corresponding management system and standard operating norms, when the medical device clinical trial institutions should submit the corresponding self-examination report. At the same time, a publicity system for extended clinical trials of medical devices should be established to accept social supervision. The publicity should include at least the following contents: the ethics committee's opinion, the necessity of conducting the extended clinical trial, and the summary of the extended clinical trial protocol.
Article 7 Before carrying out extended clinical trials of medical devices, the sponsor shall file with the drug regulatory department of the province, autonomous region or municipality directly under the Central government, and the clinical trial institution of medical devices shall report to the local health administrative department.
The drug regulatory department that accepts the record shall report the record to the drug regulatory department at the same level where the clinical trial institution is located.
The drug regulatory departments and health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the supervision and administration of extended clinical trials of medical devices in accordance with their respective responsibilities.
Article 8 Extended clinical trials of medical devices shall not affect the process of clinical trials of corresponding medical devices. Sponsors shall actively and conscientiously apply for the registration of experimental medical devices in China.
Article 9 Sponsors, researchers and clinical trial institutions shall not charge fees for medical devices used in extended clinical trials.
Chapter three start-up conditions
Article 10 The use of medical devices for extended clinical trials shall be consistent with ongoing or concluded clinical trials, and their scope of application shall not exceed the scope of application confirmed by ongoing or concluded clinical trials.
Article 11 Extended clinical trials of medical devices shall be conducted in the institutions that have carried out clinical trials of the medical devices, and shall be proposed by patients, sponsors or researchers.
Article 12 For patients with life-threatening diseases for which no effective treatment is available, the risk caused by the use of experimental medical devices is determined by the investigator to be no greater than the risk of the disease itself, and the expected benefits should outweigh the possible harm.
Article 13 A medical device clinical trial institution shall have the organizational management and quality control capabilities suitable for extended clinical trials of medical devices, and meet the following conditions:
(1) It has the qualification of third-class A medical institution, has carried out the research and treatment of the same disease, has the advanced clinical professional level in China, and has the diagnosis and treatment items suitable for the proposed extended clinical trial;
(2) A physician who is able to use medical devices for extended clinical trials and has relevant experience in use or training;
(C) have a high level of medical device management, has established a sound medical device use quality management system, with medical device use evaluation and medical device adverse event monitoring capabilities.
Article 14 The main investigator of medical device extended clinical trials should have a senior title and have participated in more than 3 medical device clinical trials.
Article 15 The sponsor shall, together with the researcher, prepare evaluation materials in accordance with the requirements of this chapter for ethical review.
Article 16 The ethical review of extended clinical trials of medical devices shall involve the professional doctors who use the medical devices.
Article 17 The Ethics Committee shall strictly review the benefit and risk analysis report, clinical trial protocol and related documents of medical device extended clinical trial to ensure that the trial complies with the Quality Management Standards for Medical Device Clinical Trial and the corresponding requirements of these provisions.
Chapter four process management
Article 18 Sponsors shall monitor and verify extended clinical trials of medical devices, and conduct regular safety and efficacy evaluations together with researchers, and may suspend or terminate extended clinical trials when necessary.
Article 19 In the course of extended clinical trials of medical devices, it is found that there may be serious device defects in the experimental medical devices, the researcher and sponsor shall suspend or terminate the extended clinical trials, and timely report to the clinical trial management department of medical devices of the clinical trial institution.
Article 20 The ethics committee shall terminate the extended clinical trial of medical devices under any of the following circumstances:
(1) the rights and interests of the subjects cannot be protected;
(b) there are serious adverse events that may be related to the experimental medical device, or there are clinical trial results that do not reach the expected efficacy, and the ethics committee considers that the risks of the extended clinical trial outweigh the benefits;
(C) the medical device clinical trial program has been greatly adjusted, but the corresponding extended clinical trial program has not been re-evaluated;
(4) The latest research shows that there are ethical or scientific problems in extended clinical trials of medical devices.
Article 21 If one of the following circumstances occurs during the development of an extended clinical trial for medical devices, the clinical trial shall be automatically terminated. Sponsor, researcher, ethics committee should start the termination procedure in a timely manner, and report to the clinical trial management department of medical device clinical trial institution:
(1) experimental medical devices or medical devices similar to them have been approved for sale in China;
(2) a treatment method equivalent to the safety and effectiveness of the experimental medical device has been used in clinical practice;
(3) the application for medical device registration for experimental medical devices is not approved;
(4) There is a violation of these provisions.
Article 22 An extended clinical trial of medical device that has been suspended shall not be resumed without the consent of the ethics committee.
Chapter V Data collection
Article 23 The collection and submission of medical device extended clinical trial data shall be legal, true, complete, accurate and traceable.
Article 24 The analysis and evaluation of medical device expansion clinical trial data mainly focuses on safety data, and on this basis, effectiveness data can be taken into account to conduct a comprehensive evaluation of the products to be registered.
Article 25 The evaluation of the safety data of extended clinical trials of medical devices mainly focuses on the occurrence of adverse events and their incidence, duration and severity during the use of experimental medical devices to evaluate the expected risks of experimental medical devices.
Article 26 When applying for the registration of medical devices, it is possible to submit the extended clinical trial plan of medical devices and the extended clinical trial data of medical devices, and analyze and evaluate the data to form an analysis and evaluation report.
Chapter VI Supplementary Provisions
Article 27 The State Drug Administration and the National Health Commission shall be responsible for the interpretation of these provisions.
Article 28 These provisions shall come into force as of the date of promulgation.
