Medical network - on May 25, according to the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) the relevant requirements, the part for drug registration application problem of clinical trial data is not real or even fraud on July 22, 2015, the state food and drug supervision and administration bureau issued" about a drug clinical trial data comprehensive inspections of announcement no. 117 (2015), organizations have to declare to manufacture or import of pending drugs for clinical trial data verification work. 

 

Since then, the state food and drug supervision and administration bureau has issued "about eight enterprises 11 announcement of drug registration applications will not be approved by the no. 229 (2015)," about 14 companies 13 announcement of drug registration applications will not be approved by the no. 260 (2015), "about 7 companies announcement of six drug registration applications will not be approved by the no. 92 (2016). 

 

Mentioned in the above statement in drug clinical trial activity data of untrue, incomplete and the problems such as nonstandard, violated the pharmaceutical administration law of the People's Republic of China and its implementing regulations and the quality control standard for clinical trials (GCP) concerned regulation, bring hidden trouble to the drug safety, efficacy, serious impact on public safety. 

 

The report on the processing of the relevant issues found in the examination of the pharmaceutical clinical trial data of the state administration of food and drug administration is as follows: 

 

The responsibility of the applicant, the pharmaceutical clinical trial organization and the contract research organization: 

 

(a) the applicant is the drug registration applicant and holder, must ensure that the application for registration of clinical trial data are true, complete and standard, supervise the implementation of the clinical trial project, reliability of the application materials and the related test data quoted bear legal responsibility. 

 

(2) the researchers implement clinical trial projects entrusted by the applicant and must ensure that the test behavior comply with GCP, ensure the test data are true, complete, standard and traceable, the authenticity, integrity, the standardization of clinical trial data to undertake legal responsibility directly. Clinical trials are the direct management of clinical trials, which are responsible for the authenticity, integrity and standardization of clinical trial data. 

 

(3) the clinical trial contract research organization authorized by the applicant, to undertake clinical trial related work, for clinical trial data authenticity, integrity, and normative laws and agreed in the contract responsibility; Bear direct legal responsibility for the reports and data issued by them. 

 

Second, in violation of the GCP article 6, article 20, article 26, article 27, 40, 48, 49, sixty-two the provisions of the following ACTS, such as data belong to fraud: 

 

(1) to make up or not rationally interpret the subject information and test data, test records and test drug information; 

 

(2) to reference preparations replacement test preparation, to test alternative reference preparation or take the market to buy drugs developed by alternative experiment with drugs, and using a false test in other ways to use drugs; 

 

(3) to conceal the experimental data, discard the experimental data in a reasonable way, and in other ways violate the experimental data by using the experimental data selectively; 

 

(4) concealing serious adverse events related to the use of drugs in clinical trials, and concealing the serious adverse events that may be associated with clinical trial drugs; 

 

(5) to conceal the combination drugs prohibited by the experimental scheme; 

 

(6) deliberately damaging, hiding clinical trial data or data storage media; 

 

(7) other cases where the data of clinical trial data of the drug are intentionally destroyed. 

 

Three, inspection found that the applicant, drug clinical trial institution, contract research organization directly responsible persons and the main researchers are listed in article 2 data to fraud, according to law by the state food and drug administration bureau to handle the following principles, suspected of a crime, handed over to the judicial organs handling: 

 

(a) on November 11, 2015 "about several policy announcements for examination and approval of the drug registration review" (the state food and drug supervision and administration bureau announcement no. 230, 2015, hereinafter referred to as the announcement no. 230) verification discovered after the release of the drug clinical trial data, on the basis of the pharmaceutical administration law of the People's Republic of China regulations on the implementation of the sixty-fifth regulation, for drug clinical trial data of applicants, since the administrative punishment or administrative punishment decision, as of the date of three years do not accept its application for the variety of drug registration. 

 

(2) to 230 inspectors discovered after the announcement of the drug clinical trial data of the applicant, since the date of administrative punishment or administrative punishment decision, not accept the application for all drug registration within a year, has been accepted shall not be approved. 

 

During being punished the applicant if it is urgent clinical needs of drug market, can according to the relevant provisions of the application, managed by the state food and drug administration drug approval center (hereinafter referred to as the center of human medicinal) organization expert reasoning, submitted to the state food and drug administration bureau to make a decision. 

 

On no. 230 (3) verification discovered after the announcement of the drug clinical trial data fraud involved in the clinical test units, professional involved shall be ordered to make rectification within a time limit, the rectification period shall not undertake drug clinical trials, drug clinical trial has undertaken shall not be into the new cases of the group; Do not accept the information of the study before the rectification is completed. Professional rectification after the completion of clinical trials should entrust the third party review, and apply to the administration of state food and drug supervision and administration, after checking through clinical trials qualification; If the examination is not passed, the clinical trial qualification shall be cancelled. 

 

All accepted registrations for the study of major researchers have been suspended from examination and approval. 

 

The clinical test units the same professional has two or more clinical trial data to fraud, their professional finish all have to accept the application for registration of clinical trials for examination and approval of the review. 

 

Clinical trial institution has three or more clinical trial data to fraud, revoke the clinical test units, the agency completed all have to accept the application for registration of clinical trials for examination and approval of the review. 

 

(4) is the second data fraud behavior of listed species, the state food and drug supervision and administration bureau will deal directly with the applicant's legal representative and the drug registration filings on those responsible to sign the name. If people think there are other the responsibility of the applicant, can in this announcement to the administration of state food and drug supervision and administration within one month, the report details and indicate its responsible administration of state food and drug supervision and administration of research process after check. 

 

(5) for the third clause to suspend the review for examination and approval of specific varieties, notify the applicant by the state food and drug administration bureau, and to the public. The applicant within 15 days after receiving notification to the state food and drug supervision and administration bureau to apply for withdrawal, as the initiative withdrawal application, according to voluntarily withdraw the relevant policy processing. The applicant that the clinical trial data real, can make a reasonable explanation and to provide evidence to prove that, to the state food and drug supervision and administration bureau to apply for the inspection. If the examination and approval is confirmed by the verification, it shall be investigated according to law. 

 

(6) if the data is incomplete and not standardized to the clinical trial, the application for registration shall not be approved; Exist only data is not standard, through additional information can be perfect, by the state food and drug administration bureau requirements that applicants one-time, supplement in accordance with the procedures for examination and approval of the review. 

 

(7) according to article 2 of drug clinical trial data of drug registration applicant and organization code, as well as project director, a list of the arbitrator and other directly responsible persons, the clinical test units list and organization code and researchers and other directly responsible persons list, list of contract research organization and organization code, as well as project director, the arbitrator and other directly responsible personnel list of information, in the administration of state food and drug supervision and administration of the applicant, drug clinical trial institution, contract research organization when the punishment decision shall publish to the society, and included in the blacklist. 

 

Four, one of the following circumstances, shall be ordered to drug clinical trial institution rectification, the rectification period shall not undertake drug clinical trials, has undertaken the drug clinical trial shall not be into the new cases of the group; If the correction is not made according to the requirements, it shall be investigated in accordance with the law. 

 

(a) without the consent of the subjects were informed, or the subjects did not sign the informed consent, namely against scheme of subjects in clinical trials related operations; 

 

(2) knowing that there may be a safety hazard in the course of the clinical trial, and still not taking effective measures to effectively protect the subjects and affect the subjects' safety; 

 

(3) the use of drugs for the use of drugs and the use of improper use shall affect the safety of the subjects; 

 

(4) to give some clinical trials job to no relevant qualification units or personnel, affect the subjects' rights and interests, security and drug clinical trial results; 

 

(5) in violation of the relevant laws, regulations and other drug clinical trials on the quality control standard for clinical trials, significantly affect the rights and interests of the subjects, the safety and quality of the drug clinical trial data. 

 

The specific circumstances of the punishment shall be given in the light, light, mitigation and exemption of punishment. Those who refuse, evade or obstruct the inspection shall be given a heavier punishment in accordance with the law and shall be put on the blacklist. To actively cooperate with the regulatory authorities in the investigation and verification of the work, to make timely explanations and to handle the application for the existence of the problems, the punishment may be lighter or mitigated according to law. 

 

According to the state food and drug supervision and administration bureau's announcement, actively carry out inspection, take the initiative to report problems, take the initiative to withdraw the application, may be exempted from administrative punishment: 

 

(a) the applicant before the verification voluntarily withdraw the application for registration, based on "about drug clinical trial data check list of announcement (the state food and drug administration administration announcement no. 169, 2015), immune from administrative penalty; About the applicant may, in accordance with the drug clinical trial data check list check the withdrawal announcement of varieties to declare related matters (the state food and drug administration bureau announcement no. 113, 2016) the relevant requirements to carry out or complement clinical trials. 

 

(2) the clinical test units, contract research organization inspection found that the data is not real, take the initiative to put the specific varieties, the applicant's name, and false specific questions to the state food and drug supervision and management of taxation and local provincial food and drug administration report, inform the applicant at the same time, may be exempted from administrative penalty. 

 

Plan published online in the inspection before the administration of state food and drug supervision and administration will not be the real data of varieties and notify the applicant for drug registration, the applicant within 15 days upon receipt of notification to the administration of state food and drug supervision and administration of the provincial food and drug administration and subjected to withdraw the application, according to the active withdrawal of treatment; Fails to apply for withdrawal, and in the administration of state food and drug supervision and administration of the inspection and verify the clinical test units and contract research organization report problems, a heavier is investigated according to law. 

 

The rights of remedy and the remedies of the parties concerned. 

 

For data fraud crime punishment by the deparment in conjunction with the food and drug administration of the state food and drug supervision and administration bureau audit inspection center (hereinafter referred to as the inspection center), human medicinal center in the name of the state food and drug supervision and management of administration decision; Processing involves the integrity and normative problems, by the state administration of food and drug supervision and administration of drug registration management together with the verification center, human medicinal cosmetics center in the name of the state food and drug supervision and management of administration made a decision. 

 

Before the decision is made, a written hearing shall be heard and the parties shall submit it within 3 days. The interpretation and interpretation of the parties shall be disclosed to the public at the time of the decision of the punishment. If the parties are not satisfied with the decision of punishment, they may apply for administrative reconsideration or bring an administrative suit in accordance with the law. The state food and drug administration shall handle administrative reconsideration cases in accordance with the law and may, if necessary, conduct hearings or listen to the advice of the expert advisory committee. 

 

I hereby announce that. 

 

The general administration of food and drug administration 

 

On May 22, 2017