Medical network - on April 11, the state food and drug supervision and administration bureau drafted on the drug clinical trial data verification issues related to deal with the announcement of opinion (draft) ", in August 2016 on September 18, 19 solstice to solicit opinions from the public for the first time received the pharmaceutical enterprises, medical institutions, contract research organization and industry associations and other unit and individual feedback on 280. Administration of state food and drug supervision and administration combined with modified feedback. 

 

In the process of change, the state food and drug supervision and administration bureau adhere to, in accordance with requirements of the laws and regulations, clear lines, investigate clinical trial data in the application for registration fraud behavior; At the same time, from set out actually, the difference is not subjective intent, and other objective conditions affect the judgement, give remedial measures. Adopted reasonable opinion suggestion, mainly summarized six items: 

 

One, for the data of fraud behavior, is not included in the omission of serious adverse events may be associated with drug clinical trials and the omission of test scheme is the merger of the banned drugs, and so on and so forth. 

 

Second, of the applicant for drug clinical trial data during the period of being punished involved varieties, such as it is urgent clinical needs, can put forward special request, after the administration of state food and drug supervision and administration organization expert argumentation, make a decision on whether to accept. 

 

Three, for data fraud involved in drug clinical trial institution, rectification within a time limit by the clinical trial institution is adjusted for professional involved rectification within a time limit. 

 

Four, for data fraud involved in the main researchers, study all have to accept the application for registration of the changed from shall not be approved to suspend the review for approval. 

 

Five, for data fraud involving varieties, clear procedure of handling personnel, adjust the publish to the society and the content of the blacklist. 

 

Six, for processing and the reconsideration of the parties, increase the related content, clear the specific procedures and methods. 

 

There are 3 items not adopt the opinions of the suggestion induction: 

 

A, Suggestions according to the found that the proportion of false data processing, percentage in the hours of administrative penalty. Laws and regulations are based on the nature of the offence itself to qualitative, specific number is the plot. Administration of state food and drug supervision and administration of the drug clinical trial data verification found fraud after the termination of the verification process, without complete drug clinical trial data verification case, does not guarantee that other real data. Use found fraud data processing scale, lack of legal basis. This item not by. 

 

Second, suggested that only the data of clinical testing institutions and researchers are punished, not the applicant. According to the laws and regulations, the applicant drug registration and bear corresponding legal responsibilities. The applicant is in drug clinical trials of the trustor and the beneficiary, must ensure that the application for registration of clinical trial data are true, complete and standard, is related to legal responsibility main body. This item not by. 

 

Three, advice, information is not included in the concrete arbitrator in blacklist. Will build system of the blacklist, a list of specific, strengthen the responsibility of specific inspection personnel and open to the society, is to facilitate effective monitoring drug clinical trial project implementation the responsibility of the applicant to carry out the measures. This item not by. 

 

State food and drug supervision and management of administration will now be revised on the drug clinical trial data verification issues related to disposal announcement (amended) again to solicit opinions from the public. On April 21, 2017 will be in the form of an email feedback opinions administration of state food and drug supervision and administration of pharmaceuticals cosmetics registration management. 

 

Contact: Luo Xiaowen 

 

E-mail: luoxw@cfda.gov.cn 

 

Attachment: about the comments of the drug clinical trial data verification issues related to the announcement (amended) 

 

The food and drug supervision administration office 

 

On April 7, 2017 

 

The attachment 

 

On drug clinical trial data verification announcement about the comments of the problem 

 

According to the state council on reform of the opinions of the drug review of medical equipment examination and approval system "(guo fa [2015] 44) the relevant requirements, part for drug registration application in the clinical trial data is not real or even fraud problem, 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 a "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. Will now be found in the drug clinical trial data verification issues related to the processing of public comment as follows: 

 

One, the applicant, the responsibility of the drug clinical trial institution and 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. The clinical test units is drug clinical trial project manager directly, the authenticity, integrity and fairness of the clinical trial data management oversight responsibility. 

 

(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; To issue the relevant report and data to undertake legal responsibility directly. 

 

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: 

 

(a) make up or no reasonable explanation to modify the participants information and test data, test records, test drug information; 

 

(2) to reference the replacement patients medication, medication in test group 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 hide, abandoned, or otherwise in violation of the testing scheme of selective use test data; 

 

(4) reported serious adverse events may be associated with drug clinical trials; 

 

(5) to hide the merger of the banned drugs the test program; 

 

(6) intentionally damaged, concealing clinical trial data or data storage medium; 

 

(7) other vandalism drug clinical trial data authenticity. 

 

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 in 2015, no. 230, hereinafter referred to as the 230th announcement) 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; Before completion of the rectification does not accept the data involved in the research of notifications. 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; Check through, cancel the qualification of clinical trials. 

 

The main researchers involved in the research of all have to accept the application for registration for examination and approval of the review. 

 

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 after check together. 

 

(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. By the verification case continue to review the examination and approval, will be investigated in accordance with the law is not true. 

 

(6) for clinical trial data is incomplete, is not standard, not enough to prove that drug safety and effectiveness, the 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 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; No rectification as required, to investigate and punish according to 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 the potential safety hazard in the process of clinical trials, has yet to take effective measures to protect the subjects, affecting the safety of the subjects; 

 

(3) the experimental drug storage, improper use, affecting 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. 

 

Five, a heavier, specific conditions of given a lighter or mitigated punishment or be exempted from punishment. Refuse, evade, hinder the inspection, be given a heavier punishment according to law, blacklisted; Actively cooperate with regulatory investigation and verification, timely work and deal with the problems of the application for registration, may be given a lighter or mitigated punishment in accordance with 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. 

 

Six, treatment and remedies of the parties rights. 

 

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, managed by the state food and drug administration drug cosmetics registration department under the state council in conjunction with the verification center, human medicinal center in the name of the state food and drug supervision and management of administration made a decision. Punishment decision before proceeding will listen to statements of the parties in writing, the parties shall, within 3 days. The interpretation of the parties and accept the explanation, the penalty decision shall be open to the society. After the punishment decision, the parties disaffected, can apply for administrative reconsideration in accordance with the law, by the state food and drug administration bureau organization reconsideration. May, when necessary, conduct hearings or listen to the opinions of the expert advisory committee.