Medical equipment clinical trial inspection reshuffle: 51 companies withdrew, 4 companies exposed for fraud

A few days ago, the CFDA official website announced the "Announcement of 51 Enterprises Withdrawing 101 Medical Device Registration Application Items (2016 No. 146)". The announcement shows that since the CFDA issued "On the Implementation of Clinical Trial Supervision of Medical Devices" on June 8, 2016 After the Notice of Spot Checking, as of August 25, a total of 51 enterprises withdrew 101 medical device registration applications. Please refer to the attachment at the end of the article for the withdrawal list.

In addition to announcing the withdrawal list, the CFDA also announced the "Announcement on the Status of Clinical Trial Supervision and Random Inspection of 4 Medical Device Registration Application Items (2016 No. 147)". On July 8, 2016, CFDA issued the "2016 The first batch of medical device clinical trial supervision and random inspection projects" has selected 10 registration application projects from 10 companies and implemented retrospective supervision and inspection on the authenticity and compliance of clinical trial data. The announcement showed that 4 of the 10 random inspection projects were found to have problems with the authenticity and compliance of clinical trials. They are:

(1) Xiamen Bosheng Biotechnology Co., Ltd. Hepatitis E virus IgM/IgG antibody detection kit (colloidal gold method) (Acceptance number: quasi 15-1744)

In the clinical trials carried out by the Third People’s Hospital of Liaoning Province, the clinical trial institution could not provide the original records related to the trial; the test samples were from our hospital and out of the hospital. The samples of our hospital cannot be traced in the in-hospital HIS system or the medical records. Receiving records, but no traceability, some samples have no original records for storage and use, and there are no original records for the retention and destruction of samples; the information provided in the clinical trial report appendix "Clinical trial data record form" submitted by the registration application is kept with the clinical trial organization. The remark information in the "raw data detection record table" is inconsistent.

In the clinical trials carried out by the Third Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, the clinical trial institution cannot provide the original records related to the clinical trial; the sample cannot be traced to the source, the sample numbering method cannot be explained, and there are no links in the preservation, use, retention and destruction of the sample The original record; the clinical trial plan and report in the submitted registration application are inconsistent with the clinical trial plan and report kept by the clinical trial organization; the relevant data of the clinical trial report appendix "Clinical trial data record form" and the clinical trial organization Relevant data in the stored "raw data detection record table" is inconsistent, for example: more than 20 cases of sample numbers are inconsistent.

(2) Hepatitis B virus e antigen determination kit (chemiluminescence method) of Sichuan Mike Biotechnology Co., Ltd. (Acceptance number: quasi 15-2788)

In the clinical trial carried out by the Second West China Hospital of Sichuan University, the clinical trial plan stipulated that the test sample type was 350 cases of serum, while the actual laboratory test sample type was plasma, and the sample type in the clinical trial report was serum.

(C) German ORGENTEC Diagnostika GmbH anti-soluble liver antigen antibody assay kit (enzyme immunoassay) (acceptance number: Jin 15-1679), the agent is Tianjin Xiupeng Biological Technology Development Co., Ltd.

In the clinical trials carried out by Tianjin People’s Hospital, the clinical trial plan stipulates that the serum samples of the medical personnel routinely measured in the inspection department of the clinical trial institution shall be randomly selected, but the samples used in the clinical trial are provided by the applicant and cannot be Traceability.

(4) The absorbable hemostatic collagen sponge of Bioland Co., Ltd. (Acceptance number: Jin 15-2682), represented by Wuxi Huawei Pharmaceutical Co., Ltd.

In a clinical trial conducted by the Second Artillery General Hospital of the Chinese People's Liberation Army, the original disease history record showed that the subject with the number 2090 had an incision infection on the 10th postoperative day, but the clinical trial report showed that all patients did not have postoperative infection. Not consistent with the actual situation.

The above inspection results show that there are "clinical trial data cannot be traced to the source" in these 4 registration items, the remarks information in the appendix "Clinical trial data record form" of the clinical trial report submitted with the registration application and the "original data detection record kept by the clinical trial institution" Remarks in the "Table" are inconsistent, "the test sample is not true", the clinical trial report is not consistent with the actual situation, and other issues, and according to the "General Administration Announcement on the Supervision and Random Inspection of Medical Device Clinical Trials (2016 No. 98)", as long as If one of the above situations exists, the conclusion of the inspection must be determined to be a question of the authenticity of the clinical trial.

CFDA did the following to deal with this:

1. The above four registration application items will not be registered.

2. According to Article 78 of the Administrative Licensing Law of the People's Republic of China, the above four registration application items will not be accepted again within one year from the date of non-registration.

3. If the above four registration application projects are suspected of issuing false reports, they shall instruct the relevant provincial food and drug administrations to investigate and handle them in accordance with the relevant provisions of the Medical Device Supervision and Administration Regulations and report to CFDA.

At the same time, CFDA stated that in October, CFDA will organize the second batch of medical device clinical trial supervision and random inspection. Applicants for registration should carefully check their medical device registration application items under review and take the initiative to withdraw problems. After the CFDA announced the list of the second batch of medical device clinical trial supervision and random inspection items in 2016, it will no longer accept applications withdrawn by registered applicants included in the scope of supervision and random inspection.