Guangxi: A registered project was killed after a clinical trial flight test
On July 28th, the Guangxi Zhuang Autonomous Region Drug Administration posted a notice on its official website regarding the flight inspection of the clinical trial of the glycosylated hemoglobin assay kit (latex enhanced immunoturbidimetry) produced by Guangxi Runmeng Medical Technology Co., Ltd.
The notice states that in May, the bureau organized a flight inspection of the clinical trial of Guangxi Runmeng Medical Technology Co., Ltd.'s under review medical device product glycosylated hemoglobin test kit (latex enhanced immunoturbidimetry) (acceptance number: Gxzf Proj-2017-13148).
As a result, the product applied for registration was found to have authenticity issues in clinical trials, mainly including:
1. In the clinical trials conducted by Gezhouba Group Central Hospital, the clinical trial institutions used whole blood samples, which is inconsistent with the serum samples shown in the clinical trial protocol and clinical trial reports; Clinical trial samples cannot be traced in the hospital LIS system; The clinical trial samples have been destroyed, and there are no original records of sample retention and destruction, making it impossible to verify whether the clinical trial samples are using serum or whole blood; The original test data has not been retained on the inspection instrument and has been deleted or backed up, making it impossible to trace the source.
2. In the clinical trials conducted at the 161 Hospital of the People's Liberation Army, it was verified on site that the clinical trial plan and report provided by the hospital were consistent with the enterprise registration application materials, and serum samples and latex enhanced immunoturbidimetry were used. However, according to the testing routine, glycated hemoglobin in the human body is generally mainly present in red blood cells, with low or no levels in plasma and serum, making its detection clinically meaningless; The clinical trial samples have been destroyed, but the destruction records have not been signed, and the samples cannot be traced; The test data in the clinical trial testing instrument has been deleted and there is no backup, making it impossible to trace the source.
The Guangxi Food and Drug Administration has decided not to register the registration application project and has agreed to withdraw the registration application for 11 projects, including the total protein assay kit (biuret method), which was conducted in clinical trials at the same time at the aforementioned two medical institutions by Guangxi Runmeng Medical Technology Co., Ltd.
Clinical trials can really be fly tested
Since its inception, flight inspection has been widely implemented in the field of medical device production. From domestic to local, a large number of medical device production enterprises have been subjected to flight inspection and then ordered to rectify or suspend production.
In the past two years, flight inspections have begun to spread to the field of medical device circulation and use. In many places, many medical device operating enterprises and user units have also been subjected to flight inspections and then ordered to rectify or suspend operations.
As for the clinical trial flight inspection of medical devices, the domestic drug regulatory bureau should have not done it yet, and the Guangxi bureau has set a precedent. So, is clinical trial flight inspection feasible?
In the "Measures for Flight Inspection of Pharmaceutical and Medical Devices" issued by the China Food and Drug Administration and implemented from September 1, 2015, it is stipulated as follows:
Under any of the following circumstances, the food and drug regulatory department may conduct flight inspections of pharmaceutical and medical devices:
（1） Complaints and reports or clues from other sources indicate that there may be quality and safety risks;
（2） Those found to have quality and safety risks during inspection;
（3） Monitoring of adverse drug reactions or adverse medical device events suggests potential quality and safety risks;
（4） Those who have doubts about the authenticity of the application materials;
（5） Suspected of serious violation of quality management standards;
（6） The enterprise has a serious record of dishonesty;
（7） Other situations that require flight inspections.
Obviously, the registration and application materials for medical device products can initiate flight inspection work, and clinical trial flight inspection is also within the scope of the drug regulatory authority.
At present, in accordance with the unified requirements of the State Administration for Drug Administration, drug regulatory authorities across China are also strengthening the supervision and management of clinical trials of medical devices. In the future, like the Guangxi Bureau, there will be more and more cases of directly initiating flight inspections for clinical trials of registered medical device products.
