CDE Announces "Safety Information Assessment and Management Code (Trial) for Drug Clinical Trials"

Guide: Implement the main responsibility of the applicant in safety information reporting and risk management during drug clinical trials, and do a good job in the evaluation and management of safety information during drug clinical trialsSafety Information Assessment and Management Code (Trial) During Drug Clinical Trials (Trial)Chapter 1 General ProvisionsArticle 1 To implement the main responsibility of applicants in safety information reporting and risk management during drug clinical trials, to do a good job in the evaluation and management of safety information during drug clinical trials, and to formulate these regulations in accordance with the Drug Administration Law and the Measures for the Administration of Drug RegistrationArticle 2 Drug Clinical Trials, the applicant shall actively cooperate with the clinical trial institutions and other relevant parties to strictly implement the main responsibility for safety risk managementDrug alert systems and systems should be established, risk monitoring, identification, evaluation and control should be carried out, safety problems and risks should be detected in a timely manner, and necessary risk management measures should be taken, such as adjusting clinical trial programs, actively suspending or terminating clinical trialsThe effectiveness of security risk management measures should also be evaluated to ensure that subjects are minimized in risk and that they are safeFor safety risk-related issues arising in drug clinical trials, the applicant shall promptly report the relevant risks and management information to the drug supervision and administration departmentArticle 3 To encourage applicants, clinical trial agencies and the Drug Review Center of the State Drug Administration (hereinafter referred to as the "Drug Review Center") to actively communicate with applicants, clinical trial agencies and the Drug Review Center of the State Drug AdministrationChapter II Risk Assessment and ManagementThe First Application Risk Assessment and ManagementDuring the Article 4 Clinical Trial, the applicant shall submit a suspicious and unexpected serious adverse reaction (SUSAR) case report in a timely manner through the Drug Alert Electronic Transmission System (PV System), and submit the Safety Update Report (DSUR) and other potential serious safety risk information reports on time through the Drug Review Center websiteSUSAR case reports and other potentially serious safety risk information reporting requirements are implemented in accordance with the Drug TrialS Rapid Reporting Standards and Procedures for Safety Data During Drug Clinical Trials issued by the Drug Review CenterDSUR related requirements are implemented in accordance with the "Safety Update Report Management Regulations (Trial) issued by the Drug Review Center."changes in clinical trial scenarios, non-clinical or pharmaceutical changes, or new discoveries during clinical trials, the applicant shall fully assess the impact on the safety of the subjectsIf the assessment does not indicate that the safety of the subject should be reported in the DSUR, and if the risk of safety of the subject may be increased, a supplementary application should be madeArticle 5, the applicant shall conscientiously fulfill the main responsibility of risk management of drug clinical trials, carry out risk monitoring, identification, evaluation and control of safety information, promptly identify safety problems or other risks, and take risk control measures and risk minimization measures in a timely manner, including general risk management measures (such as modifying clinical trial programs, etc.), and voluntarily suspend or terminate clinical trials Article 6 If the applicant considers that there is a certain safety risk in a clinical trial, the applicant shall adopt general risk control measures, such as modifying the clinical trial program, modifying the researcher's manual, modifying the informed consent form, etc Article 7 Applicants who assess that clinical trials have a high eras of safety risk seis ionica shall voluntarily suspend clinical trials Reference criteria and conditions for suspending clinical trials due to safety risks are referred to in Annex 1 Article 8 If an applicant evaluates that there is a significant safety risk in a clinical trial, he or she shall voluntarily terminate the clinical trial Reference criteria and conditions for discontinuing clinical trials due to safety risks are referred to in Annex 2 Article 9 Applicants should take risk management measures against safety risks and assess the effectiveness of the measures implemented to ensure that the risk to subjects is minimized Information about modifying clinical trial programs, actively suspending or terminating clinical trials should be updated in a timely manner on the drug clinical trial registration and information disclosure platform Section II Risk Assessment and Management of the Drug Supervision and Administration Department Article 10 Drug Review Center shall evaluate the risk management implemented by the applicant in clinical trials on the basis of the safety information submitted by the applicant and its assessment and risk management information, combined with the specific circumstances of the original review and approval of the drug clinical trial If the assessment finds that the risk management measures implemented by the applicant are inadequate and that there are still safety risks in clinical trials, the Drug Review Center may make further risk control requirements, such as general risk control, suspension of clinical trials, termination of clinical trials, etc Article 11 The Drug Review Center, after evaluating the safety information and risk management information submitted by the applicant, believes that there are still certain safety risks in clinical trials, may require the applicant to take further risk control measures, such as modifying the clinical trial program, modifying the researcher's manual, modifying the informed consent form or adjusting the safety update reporting cycle during the research and development period, etc., and send the "Clinical Trial Risk Control Notice" to the applicant through the Drug Review Center website, and the applicant shall promptly inquire and download the applicant shall take the relevant measures in time after receiving the Notice of Risk Control of Clinical Trials and reply in writing to the completion or progress of the relevant measures through the Website of the Drug Review Center within twenty working days Article 12 The Drug Review Center may request the suspension of the clinical trial if it evaluates the safety information and risk management information submitted by the applicant and considers that there is a greater safety risk in continuing the clinical trial when the corresponding situation in Annex 1 occurs during the clinical trial, but the applicant does not voluntarily suspend the clinical trial, the drug trial center may request the suspension of the clinical trial Drug Trial Center will "suspension of clinical trial notice" through the Drug Review Center website sent to the applicant, the applicant should promptly query and download Article 13 The Drug Trial Center may request the termination of the clinical trial if it evaluates the safety information and risk management information submitted by the applicant and considers that there is a significant safety risk in continuing the clinical trial when the corresponding situation in Annex 2 occurs during the clinical trial, but the applicant does not voluntarily terminate the clinical trial, the drug trial center may request the termination of the clinical trial, and if the applicant has not implemented the clinical trial as required 20 working days after receiving the Notice of Suspension of Clinical Trials, the Drug Review Center may request the termination of the clinical trial Drug Trial Center will "termination of clinical trial notice" through the Drug Review Center website sent to the applicant, the applicant should promptly query and download Safety information reporting, risk assessment and risk management and related treatment during clinical trials shall be strictly observed in accordance with the principles of subject protection In the case of suspending and terminating clinical trials, the applicant and the researcher shall, in the case of the subject who has already started using the experimental drug, arrange the relevant matters properly, provided that they are safe and beneficial Chapter III Application for resumption of clinical trials after suspension Article 15 For the case of the applicant's active suspension of clinical trial due to safety risks, the drug trial center may, according to the severity of the risk, require the applicant to submit a supplementary application to the drug trial center for resumption of clinical trials after completion of the rectification, and only after examination and approval to resume clinical trials of drugs If the drug review center does not explicitly require the applicant to supplement the application, the applicant may, as necessary, submit an application for communication and communication in accordance with the relevant provisions of the Measures for the Administration of Communication and Communication between Drug Research and Development and Technical Review Article 16 For cases where the drug regulatory authority has been ordered to suspend due to safety risks, the applicant intends to continue the clinical trial, and shall submit a supplementary application to the drug trial center for resumption of clinical trials of drugs after the completion of the rectification, and only after examination and approval to continue the drug clinical trial Additional application materials for resumed clinical trials of drugs shall include the Notice of Suspension of Clinical Trials, responses to the reasons for the suspension of clinical trials, risk control measures and related technical information the review of the supplementary application for resumption of clinical trials, according to the results of the review, the Fda Review Center sends the Notice of Resumption of Clinical Trials or the Notice of Continuing suspension of Clinical Trials to the applicant through the Fda Review Centre website Chapter IV OF
Risk Communication Article 17 For safety risks related to drug clinical trials, the applicant may, in accordance with the relevant provisions of the Measures for communication and management of drug research and development and technical review, submit an application for communication and communication through the website of the Drug Review Center, and the drug review center shall handle the relevant provisions Drug Trial Center may communicate with applicants by telephone, e-mail, etc during the monitoring, evaluation and processing of clinical trial safety information In general, the applicant will be communicated in advance before the Clinical Trial Risk Control Notice, the Suspension Notice, or the Notice of Termination of Clinical Trials are formally issued However, in the event that the subject is at serious risk, the Drug Review Center may directly order the suspension or termination of clinical trials, and control the risk at the same time to protect the subject's safety The Drug Review Centre may also organize meetings and discussions with applicants on risk management-related matters as needed applicants should strengthen risk management in accordance with the contents of the notice, and promptly inform clinical trial institutions, ethics committees, researchers, etc., in order to effectively control the risk of clinical trials and protect the safety of subjects Chapter V by-laws of the Article 18 Of this management norm shall be implemented from July 1, 2020 Annex to the : 1 Standards and conditions for the suspension of clinical trials
2 The criteria and conditions for the termination of clinical trials Annex 1 the criteria and conditions for the suspension of clinical trials
the criteria and conditions for the suspension of clinical trials for safety reasons generally include, but are not limited to, the following: 1 The subject is or will be at risk of significant physical injury associated with the trial, with unreasonable benefits/risks; 2 Failure to submit SUSAR reports, DSUR or other potential lying safety risk information reports to regulatory authorities in a timely manner within the prescribed time limits as required; 3 Quality problems in clinical trial drugs that affect the safety of subjects; 4 Other situations that can cause subjects to face significant safety problems or risk stakes Annex 2 the criteria and conditions for the termination of clinical trials
the criteria and conditions for the termination of clinical trials due to safety issues generally include, but are not limited to, the following conditions: 1 Large-scale, unanticipated serious adverse reactions in drug clinical trials; 2 There are serious quality problems in clinical trial drugs; 3 For other reasons, the Drug Administration considers that continuing clinical trials may pose significant harm to the health of the subjects or are not in the public interest