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Medical device extended clinical trial management regulations

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On August 28th, in order to implement the spirit of the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices (Dongzi [2017] No. 42), the bureau organized the drafting of the medical The regulations for the management of extended clinical trials of drugs (draft for comments) (see annex) are now open to the public for comments.



The following is the original text:



Medical device extended clinical trial management regulations



(draft for comment)



Chapter 1 General



The first one is to further meet the public clinical needs, so that patients with urgent clinical needs can obtain medical equipment for trials as soon as possible, standardize the development of clinical trials of medical devices and collect safety data, and safeguard the rights and interests of the subjects. These Provisions are formulated by the Office of the State Council and the General Office of the State Council on the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging Innovation in Pharmaceutical Medical Devices.



Article 2 The development of medical device expansion clinical trials within the territory of the People's Republic of China shall comply with these Provisions.



Article 3 The extended clinical trials of medical devices referred to in these Provisions refer to the activities and processes of patients who have life-threatening diseases and have no effective treatment means, which can use medical devices that have not been approved for marketing in institutions that conduct clinical trials. . The use of extended clinical trial medical devices may be based on the observation of existing clinical trials that may benefit the subject, and the patient may not be admitted to the clinical trial because of the clinical trials that have been selected according to the clinical trial protocol. Use of the device.



Article 4 The medical device expansion clinical trial belongs to the clinical trial of medical devices and shall comply with the corresponding provisions of the "Quality Management Regulations for Clinical Devices Clinical Trials".



Chapter II Rights and Responsibilities



Article 5 Medical device expansion clinical trials shall follow the ethical guidelines established by the Helsinki Declaration of the World Medical Congress to protect the rights and interests of subjects.



Subjects participating in medical device extended clinical trials should be voluntary and need to sign an informed consent form. Informed consent should ensure that the subject understands that he or she will be treated for the medical device being tested, and is explicitly informed that the medical device used in the extended clinical trial has not yet obtained a domestic marketing approval, and that the medical device for testing may be safe and effective. The risk of existence. Subjects have the right to withdraw at any time during the trial.



In the ethical review, the subject's rights and interests should be fully protected. Based on the potential risks of the extended use of medical devices, considering the course of the disease, it is confirmed that the benefit of the subject is greater than the risk.



Article 6 Subjects, researchers, sponsors and clinical trial institutions conducting medical device expansion clinical trials shall sign an agreement to clarify the rights, obligations and responsibilities of all parties. Sponsors, researchers, clinical trial institutions, and ethics committees should assume their respective responsibilities in accordance with the Medical Device Clinical Trial Quality Management Practices.



In order to effectively control the quality and risk of medical device expansion clinical trials, medical device clinical testing institutions should increase the corresponding management system and standard operating specifications for the characteristics of extended clinical trials when establishing medical device clinical trial quality management system. When the clinical trial institution is filing, it shall submit a corresponding self-examination report, and at the same time establish a medical device extension clinical trial publicity system and accept social supervision. The publicity includes at least the following: ethics committee opinions, the need for extended clinical trials, and extended clinical trial programs.



Article 7 Before carrying out the extended clinical trial of medical devices, the sponsor shall file with the drug regulatory authority of the province, autonomous region or municipality directly under the Central Government, and the clinical device for clinical devices shall report to the local health and health authorities.



The drug supervision and administration department that accepts the record shall notify the drug supervision and management department at the same level as the location of the clinical trial institution.



Article 8 The sponsor shall actively and conscientiously apply for the registration of the medical device for trial in China. Expanded clinical trials of medical devices should not affect the progress of clinical trials of corresponding medical devices.



Article 9 Sponsors, researchers and clinical trial institutions shall not charge for medical devices for extended clinical trials.



Chapter III Startup Conditions



Article 10 Medical devices for extended clinical trials should be used to treat diseases that are life-threatening and have no effective treatment.



Article 11 Medical devices undergoing clinical trials may benefit from preliminary observations, or the results of clinical trials that have been completed indicate the validity and safety of medical devices within the scope of application for registration in China and the medical devices have not been approved for domestic listing. .



Article 12 Medical devices for extended clinical trials shall be used in a manner consistent with ongoing or closed clinical trials, and their scope of application shall not exceed the scope of application of clinical trials that are being carried out or have been completed.



Article 13 Medical device expansion clinical trials shall be conducted in an institution that has carried out clinical trials of the medical device.



Article 14 The investigator has determined that the risk caused by the use of the test medical device by the subject is not greater than the risk of the disease itself, and the expected benefit should exceed the damage that may occur.



Article 15 Clinical trials of extended medical devices shall not interfere with ongoing or completed clinical trials used to support domestic market approval.



Article 16 The ethical examination of medical device expansion clinical trials shall involve the participation of professional doctors using medical devices.



Article 17 Medical device clinical testing institutions shall have the organizational management and quality control capabilities appropriate to the extended clinical trials of medical devices, and have the following conditions:



(1) Class III A medical institutions have carried out research and treatment of the same kind of diseases, and the clinical professional level is domestically advanced, and has medical treatment projects suitable for the extended clinical trials to be carried out;



(2) Physicians who have registered medical institutions and are able to use medical devices for extended clinical trials, and have relevant experience or training experience;



(3) It has a high level of medical device management, has established a sound quality management system for medical device use, and has the ability to use medical device evaluation and medical device adverse event monitoring.



Article 18 The main investigators of the extended clinical trials shall have senior professional titles and have participated in more than three clinical trials of medical devices.



Article 19 The sponsor shall, in conjunction with the researcher, form an assessment document in accordance with the above requirements for use in ethical review. The ethics committee shall strictly review the medical device expansion clinical trial plan and related documents to ensure that the test meets the requirements of the "Quality Management Regulations for Clinical Devices Clinical Trials" and the corresponding requirements of these regulations.



Chapter IV Process Management



Article 20 The sponsor shall conduct audits and verifications on the extended clinical trials of medical devices carried out in the clinical trial institutions of medical devices, and conduct regular safety and efficacy evaluations with the investigators, and may suspend or terminate the trials if necessary.



Article 21 The sponsor shall submit the progress report to the drug regulatory authority of the province, autonomous region or municipality directly under the Central Government once a year, until the application for domestic registration is submitted and the review and approval of the drug regulatory authority is completed. The clinical trial and testing institution shall submit a progress report to the local health and health authorities once a year until the extended clinical trial ends or is terminated. The date of each report is based on the date of the first filing of the medical device expansion clinical trial. The progress report shall include at least a summary of the progress of the application for medical device application for trial use, sample size of the subject, indications, follow-up, preliminary, phased, and complete safety and efficacy data obtained from the extended clinical trial of the medical device. The drug regulatory authority can conduct on-site inspections.



Article 22 If one of the following situations occurs during the extended clinical trial of a medical device, the researcher and the sponsor shall suspend or terminate the extended clinical trial of the medical device and promptly report to the clinical trial management department of the clinical device:



(1) There are serious adverse events that may be related to the trial medical device;



(2) The medical device for testing may be found to have serious quality defects during the test;



(3) Other circumstances in which the clinical trial of medical devices should be suspended or terminated.



Article 23 The suspended clinical trial of medical devices shall not be resumed without the consent of the ethics committee.



Article 24 If one of the following situations occurs during the extended clinical trial of medical devices, the ethics committee shall terminate the extended clinical trial:



(1) The subject's rights cannot be guaranteed;



(2) The sponsor failed to submit the progress report on the extended clinical trial of medical devices to the drug regulatory authorities of the province, autonomous region or municipality directly under the Central Government for two consecutive times; the medical institutions conducting the extended clinical trials failed to submit to the health and health authorities in time. Submit a progress report;



(3) The sponsor of the medical device expansion clinical trial did not perform the application for domestic listing;



(iv) ongoing clinical trials related to registration have been terminated;



(5) The original clinical trial plan has been greatly adjusted, but the corresponding medical device extended clinical trial plan has not been re-evaluated;



(VI) The latest research shows that there are ethical or scientific problems in the extended clinical trials of medical devices.



Article 25 If one of the following situations occurs during the development of a clinical trial of a medical device, the clinical trial is automatically terminated. The sponsor, the researcher, and the ethics committee shall promptly initiate the termination procedure and report to the clinical trial management department of the clinical trial institution:



(1) The medical device for trial or a medical device similar to it has been approved for listing in China;



(2) The treatment method equivalent to the safety and efficacy of the medical device for testing has been used clinically;



(3) The application for medical device registration for medical devices for trials has not been approved;



(4) There are circumstances in violation of these regulations.



Chapter V Data Collection



Article 26 The collection and submission of medical device expansive clinical trial data shall be legal, true, complete, accurate and traceable.



Article 27 The analysis and evaluation of medical device expansive clinical trial data mainly focuses on safety data. On this basis, the validity data can be taken into account to conduct a comprehensive evaluation of the products to be registered.



Article 28 The evaluation of the safety data of medical device extended clinical trials mainly focuses on the adverse events occurring during the use of medical devices for trial use, their incidence, duration, severity and acceptability of subjects to evaluate The expected risk of testing medical devices.



Article 29 When applying for medical device registration, it may submit medical device expansion clinical trial plan, medical device extended clinical trial data, and analyze and evaluate the data to form an analysis and evaluation report.



Chapter VI Supplementary Provisions



Article 30 These regulations shall be interpreted by the State Drug Administration and the National Health and Health Commission.



Article 31 These Provisions shall come into force as of the date of promulgation


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