Medical network - July 11, 2017, the first medical device clinical trials of the supervision and inspection work has been open.
This month, the CFDA YiXie authenticity large clinical trial supervision
On July 10, total bureau of national drug safety alerts, decided to the umpire for medical device registration in the conduct of clinical trials data authenticity, compliance monitoring and inspection, clinical trials to investigate and punish illegal ACTS, and the supervision and inspection and processing results to the public.
The scope of the inspection for the CFDA trial registration on June 1, 2017 in the clinical trials of projects, including all within the territory of the third class and imported medical instruments within the territory of China by way of clinical trials for clinical trial data for registration. By CFDA considers factors such as product risk level, the complaint reporting extraction check project, and spot check announcements.
Notice shows that later this month, the CFDA will inspection group of conducting on-site inspections. On-site inspection, the written notice to the corresponding clinical test units, registration applicant (agent), and provincial food and drug administration.
Three kinds of situations that fraud, the registered project dead
Notice is clear, one of three kinds of test results, will be judged to be clinical trial data authenticity problems:
1, submit the application for registration of clinical trial data and the clinical test units to save the corresponding clinical trial data are inconsistent;
2, clinical trial data cannot be traced;
3, product/test subjects with in vitro diagnostic reagents or test sample is not true.
In addition, did not find the authenticity, but clinical trial process is not in conformity with the requirements of the medical devices regulations compliance problems will be judged.
Problems of authenticity, or data of fraud, according to the administrative licensing law of the People's Republic of China regulations on the supervision and administration of medical devices of the medical device registration measures for the administration of registration measures for the management of in vitro diagnostic reagents and other relevant provisions for processing. From the point of the same kind of examination in 2016, should be, the relevant registration project will not be registered, and since the will not be registered again within one year from the date of the will not be accepted. In addition, the alleged false report issued by the clinical test units and persons responsible, will be to investigate.
The compliance problems, only for comprehensive evaluation of registration information, supervision and inspection found problems, make a decision on whether to approve registration.
From now on, there is fraud can apply for to withdraw
Notice also demanded that this registration applicant if it is thought that their clinical trial data authenticity and serious compliance problems, can apply for to withdraw. CFDA project selectiving examination announcement after, will no longer accept selected check clinical trial project registration of the applicant to withdraw the application.
Industry reshuffle storm started!
Last year, the CFDA has organized medical instrument clinical trial supervision and spot check, also is the domestic first big inspector. A total organized 2 batch of examination, to extract the 20 companies project, application for registration of the 20 clinical trials involving 40 institutions.
As a result, there are eight authenticity of the application for registration, be made shall not be registered, and will not be accepted the decision again within a year.
In addition, a total of 122 companies active withdrew 263 for medical device registration. Many provincial food and drug administration also actively carried out the second category of medical devices clinical trial supervision and spot checks.
Compared with last year, this year's medical instrument clinical trial supervision and spot check, from the point of the CFDA notice, in extraction by registration project in principle, have the obvious change.
Circular no. 98 in 2016, the CFDA is clear, "considering its degree of risk, import proportion of application, the applicant, clinical trial institution within the territory of the size and take on such factors as the number of items, according to certain proportion extraction clinical trial project (check)."
In circular no. 103, 2017 CFDA is clear, "considering factors such as product risk level, the complaint reporting extraction check project."
Obviously, this year, the complaint reporting become an important factor. And there is no smoke without fire, be complain inform against counterfeiting many often also will ultimately be confirmed that this year, the medical instrument clinical trial authenticity of the results of the inspection, is likely to be killed off more companies registered products.
CFDA big supervision in order to strengthen the supervision and administration of clinical trials, deter fraud behavior, and the related supervision work in the short term may cause a certain pressure for many enterprises and institutions, but in the long run, will promote the healthy development of industry evolution.
A new round of reshuffle, I hope you won't "unfortunate shot!" |
