Published on June 8th, 20 16.
In order to implement the Opinions of the State Council on Reforming the Examination and Approval System of Drugs and Medical Devices (Guo Fa [2015] No.44) and strengthen the supervision and management of clinical trials of medical devices, the Food and Drug Administration will supervise and inspect the authenticity and compliance of clinical trial data in the application for registration of medical devices under trial, investigate and deal with illegal acts in clinical trials, especially fraud, and strengthen the legal awareness, integrity awareness and responsibility awareness of applicants and clinical trial institutions.
I. Scope of inspection
The supervision and inspection of clinical trials of medical devices in 20 16 adopted the method of retrospective inspection, and randomly selected the clinical trial items in the application for registration pending by the General Administration of Food and Drug Administration of the United States before 20 16 June 1 day, including all domestic Class III and imported medical device registration applications that obtained clinical trial data in China through clinical trials, and comprehensively considered their risk degree, domestic application ratio and applicant situation. The General Administration of Food and Drug Administration of the United States will issue a notice on the clinical trial items sampled.
Second, the inspection basis
The US Food and Drug Administration has formulated the key points for on-site inspection of clinical trials of medical devices according to the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration (Order No.4 of the Food and Drug Administration), the Measures for the Administration of Registration of in vitro Diagnostic Reagents (Order No.5 of the Food and Drug Administration), the Provisions for Clinical Trials of Medical Devices (Order No.5 of the former US Food and Drug Administration) and the Technical Guiding Principles for Clinical Trials (Research) of in vitro Diagnostic Reagents. The US Food and Drug Administration will supervise and inspect the spot-checked clinical trial items according to the above-mentioned key points of on-site inspection of clinical trials of medical devices.
Third, the inspection procedures
The US Food and Drug Administration will form inspection teams in batches from 2065 438+06 to 2065 438+00 to conduct on-site inspections in accordance with the Procedures for On-site Inspection of Clinical Trials of Medical Devices. Before the on-site inspection, the relevant clinical trial institutions, registered applicants and the provincial food and drug administration where the clinical trial institutions and registered applicants are located will be notified in writing. The clinical trial institution and the provincial food and drug administration where the registered applicant is located each send an observer to participate in the on-site inspection and coordinate the on-site inspection process.
Fourth, the inspection results processing
The inspection conclusion shall be determined according to the following principles:
(a) in any of the following circumstances, there is a problem with the authenticity:
1. The clinical trial data submitted by the registration application is inconsistent with the corresponding clinical trial data saved by the clinical trial institution;
2. Clinical trial data cannot be traced back;
3. The in vitro diagnostic reagent or test sample of the tested product/test is not true.
(2) If no authenticity problem is found, but the clinical trial process does not meet the requirements of the relevant provisions of medical devices, it is determined that there is a compliance problem.
(3) No problems of authenticity and compliance were found, and it was judged to meet the requirements.
If there is any authenticity problem, it shall be dealt with according to the Administrative Licensing Law of People's Republic of China (PRC), Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Medical Device Registration and Measures for the Administration of in vitro Diagnostic Reagents, and the corresponding application for registration of medical devices shall not be registered. Does not involve authenticity but there are compliance problems, the registration application materials and the problems found in the supervision and inspection shall be comprehensively evaluated for safety and effectiveness, and a decision shall be made on whether to approve the registration. The supervision and spot checks and the handling results are announced to the public.
Verb (abbreviation for verb) Other matters
(a) please attach great importance to the provincial food and drug administration, implement the requirements of the food and drug administration for the supervision and spot check of clinical trials of medical devices, and urge the applicants (agents) and clinical trial institutions within their respective administrative areas to make preparations for the inspection.
(two) after the issuance of this notice, the applicant for registration may apply for voluntary withdrawal if he thinks that the clinical trial data applied for registration have problems of authenticity and serious compliance. After the General Administration of Food and Drug Administration of the United States issued the Notice of Spot Check of Clinical Trial Items, it will no longer accept the relevant registered applicants to withdraw their applications by themselves.
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Attachment: 1 Key points of on-site inspection in clinical trials of medical devices (20 16)
2. On-site inspection procedures for clinical trials of medical devices (20 16)
General administration of food and drug administration
2065438+June 8, 2006