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Announcement of the State Food and Drug Administration on the verification of the data on the clinical trial data of the drug clinical trials
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In order to implement the Party Central Committee, the State Council with "the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability to ensure the broad masses of the people diet drug safety requirements, from the source to ensure the drug safety and effective, the State Food and Drug Administration decided to annex listed has been declared the manufacture or import of the pending drug registration application to carry out verification of clinical trial data. Announcement of the matter is as follows:
, since the date of the announcement, all has been declared and in administration pending an applicant for drug registration shall be in accordance with the relevant requirements of the drug clinical trial quality management norms, ", controlled clinical trial scheme, on the declared production or import of pending drug application for the registration of clinical trials of drugs to carry out self-examination to ensure true and reliable data from clinical trials, relevant evidence intact.
Two, the contents include: (a) to check the lock of the database consistency with the original data, statistical analysis and summary report data and the original record and database consistency; data lock, whether there is a modification and modification. (two) biological sample analysis of test instruments (such as HPLC, LC-MS/MS), and other major test instruments and equipment operation and maintenance, data management software inspection module (trail Audit), the installation and operation, etc.. (three) the subjects of each clinical trial institution were screened, enrolled and excluded, and the subjects were selected and excluded. (four) the clinical trial program is contrary to the number of cases, excluding the number of cases, serious adverse events, such as the key data; hospital HIS system and other information system in patients with information, drug use and inspection of the clinical process, etc.. (five) the production or purchase, inspection, transportation, storage, transportation, storage, return and destruction of the test drug and control drug, and related notes, records, retention, etc.. (six) the collection process of biological samples and the records of the transportation and transfer and preservation, etc.; the biological sample analysis method was confirmed, and the sample of the biological sample analysis process was related to the sample. (seven) the implementation of the main responsibilities of the parties concerned in the clinical trial project and compliance.
Three, August 2015 25, the applicant should be listed on the list of varieties, to the State Food and Drug Administration of food and drug inspection and inspection center submitted to the electronic version of the report, the clinical trial contract scanning, research team personnel and other materials, as well as the legal representative of the authenticity of the signature. The specific requirements of self-examination report are detailed in the State Food and Drug Administration food and drug inspection and inspection center website: www.cfdi.org.cn (contact phone: 87559031).
Four, the applicant found clinical trial data is not true, incomplete and so on, you can in August 2015 25 to the State Food and drug administration proposed to withdraw the registration application.
Five, the provinces (autonomous regions and municipalities) food and drug supervision and management department is responsible for the administrative area of the applicant's self supervision. According to the need of supervision, we can organize the investigation of clinical trials, and the investigation object should include the clinical trial institution, contract research organization, and other related organizations. The problem found in the investigation should be promptly locked the evidence and put forward to deal with the comments, in September 2015 8 before the relevant situation will be reported to the State Food and drug administration.
Six, the State Food and Drug Administration will organize experts to the applicant's self data analysis and inspection of the case to carry out flight inspection. Inspection found that clinical trial data to make false, clinical trial data is not complete, will be based on the "people's Republic of China drug management law" 166th, "drug registration management approach," the relevant provisions of the applicant, clinical trial institutions, contract research organization's responsibility, and to the public the applicant, clinical trial institutions, contract research organizations and their legal representatives and relevant responsible personnel.
Seven, the drug review process, the applicant is found to be one of the following circumstances, will be based on the "drug registration management approach," the relevant provisions of the 154th, the registration application is not approved. Including: (a) refuse or evade or hinders examination or destruction of evidence; (II) clinical trial data no traceable, incomplete data; (III) authenticity questionable and no reasonable explanations and evidence; (4) fails to submit the inspection report.
On the verification of clinical trial data found in the authenticity of the relevant applicants, 3 years not to accept the application. The drug clinical trial institution, the existence of fraud, revoke the qualification of drug clinical trial institutions; to clinical trials exist irregularities to inform the relevant departments investigated and dealt with according to law. The applicant will resort to deceit, clinical trial institutions, contract research organizations and related responsible persons such as blacklist.
Notice.
Annex: drug clinical trial data check list
Food and Drug Administration
July 22, 2015
Drug clinical trial data check list
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