The Security Update Report Management Specification (Trial) document was published.

In order to regulate the writing and management of safety update reports during research and development, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration, the Drug Review Center has formulated the Regulations on the Management of Safety Update Reports during Research and Development (see Annex), which are approved by the State Drug Administration and are hereby issued and shall come into effect from July 1, 2020the "Annual Report on pharmaceutical research in pharmaceutical research for inchemical ind applications" (published on May 10, 2012) by the Former State Food and Drug Administration Drug Review Center," which is consistent with the safety update report during research and development, and is no longer submitted separatelyhereby hereby noticethe Drug Review Center of the State Drug AdministrationJuly 1, 2020
Article 1 To regulate the writing and management of the Safety Renewal Report (hereinafter referred to as DSUR) during research and development, and to formulate this regulation in accordance with the relevant requirements of the Measures for the Administration of Drug RegistrationArticle 2 The main purpose of DSUR is to conduct a comprehensive and in-depth annual review and assessment of the safety information collected during the reporting cycle in relation to the drug (whether or not it is listed) by the applicant for drug registration (hereinafter referred to as the applicant, including the applicant)Article 3 Applicants shall prepare, write and submit DSUR in accordance with the requirements of the International Coordinating Committee on The Registration of Human Medicines (ich) E2F Safety Update Report during Development (hereinafter referred to as e2F Guidelines)the applicant may entrust a third party (e.gcontract research organization) with the preparation, writing and submission of DSUR, but the applicant is still solely responsible for the content, quality and submission time of the DSURFor multi-party situations, such as co-development, the applicant shall divide the responsibilities for preparation and submission of DSUR in accordance with the "Responsibility of the Parties" section of the ICH E2F Guiding PrinciplesArticle 4 When preparing DSUR, applicants are required to include data relating to all dosage forms and specifications, all indications, and the population of patients receiving the drug in the study (chemicals and biological products should be prepared according to the same active ingredients, Chinese medicine sedituated on the same prescription)If the relevant information is not available (e.gthe applicant has not yet obtained the data), the applicant should explain it in the foreword section of the DSURArticle 5 The applicant shall submit DSUR to the Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) after he/she has been approved to conduct clinical trials of drugs (including Chinese medicines, chemicals and biological products)Article 6 DSUR shall, in principle, be the month and day of the first domestic or global clinical trial license date for a drug clinical trial (i.e., "International Research and Development Day", referred to as DIBD) as the start date of the annual report cycleThe initial submission should be completed within two months of the first DIBD approved for in-country clinical trial, and subsequent submissions should also be based on DIBD article 7 dSUR of the shall continue to be submitted until the last application for a listing permit in the drug is submitted, or until research and development does not continue in the territory At the time of the final submission, a note sheet should be attached stating that the submission was the last DSUR in the territory and whether the applicant continued clinical trials in other countries or regions Article 8 When a drug is licensed for listing both inside or outside the country, dSUR may be prepared and submitted on the basis of the first date of approval for listing in the world (i.e., "International Birth Day") if required After the adjustment of the first submission, the reporting cycle should not exceed one year Article 9 When submitting dSUR, the applicant shall include the following documents: 1 Full text and annexes to DSUR; 2 Supporting information for drug clinical trial sinfs or clinical, non-clinical or pharmaceutical changes that the applicant considers to be not affecting the safety of the subject during the reporting cycle applicant sands the necessary explanatory documents with DSUR, as appropriate (e.g last submission to DSUR) Article 10 Applicants shall write the DSUR and Annexes in full chapter by chapter, in strict accordance with the requirements of the ICH E2F Guiding Principles Chapters or annexes that are not progress/discoverable shall be described under the corresponding headings and shall not be omitted applicants should, in the section "Regional Specific Information", summarize the evaluation results and reporting of changes in drug clinical trial splans or clinical changes, non-clinical or pharmaceutical changes, or new findings that may increase the safety risk of subjects, and submit supporting information during the reporting cycle, in conjunction with relevant regulations, technical guidelines, etc DSUR should not be used as an initial reporting channel for new important security information, or as a way to detect new security issues Article 11 dSUR of the is reported using Chinese, and can be reported in Chinese or English for the "List of Serious Adverse Reactions during the Reporting Cycle" Article 12 When writing DSUR, the applicant is required to provide the following information under "Regional Specific Information" or in the form of an Annex to the DSUR Region: 1 Cumulative Summary of Severe Adverse Reactions (SAR), 2 List of Dead Subjects in the Reporting Cycle, list of subjects who have withdrawn from clinical trials due to any adverse events in the reporting cycle, 4 Changes in drug clinical trial programs or new findings, non-clinical or pharmaceutical changes or new findings in the reporting cycle; and 5 Summary of the overall study plan for the next reporting cycle detailed writing requirements are referred to annexes 1 to 5 and schedules Article 13 The applicant may submit to DSUR through the prescribed channels such as the website of the Drug Review Centre After examination, the drug review center will notify the applicant within 180 working days after the DSUR submission is deemed to be necessary (e.g., requiring the applicant to change the DSUR reporting cycle, supplementing corrections information, or reminding the applicant to strengthen the safety measures of the subject, etc.) The applicant shall, through the drug review center website, inquire and download the relevant notice or reminder, in the case of the need for additional correction information, the applicant shall submit the correction information within five working days from the date of receipt of the correction Article 14 This regulation shall come into effect on July 1, 2020 : 1 Serious Adverse Reactions (SAR) Cumulative Summary 2 List of Dead Subjects during the Reporting Cycle
3 List of subjects who have withdrawn from clinical trials due to any adverse events during the reporting cycle
4 Changes in drug clinical trial scenarios or new discoveries, non-clinical or pharmaceutical changes or new findings in the reporting cycle 5 Summary of the overall research plan for the next reporting cycle
the cumulative summary of serious adverse reactions (SARs) the cumulative summary of SAR should indicate the number of all SARs from DIBD, and shall be classified according to the following methods: 1 System Organ Classification (SOC ); 2 Adverse reaction terms; 3 Treatment group (if applicable) at the same time, the term scant sinned at unexpected adverse reactions should be noted applicants should refer to The E2F DSUR Example Business Bidder Appendix R1 list of dead subjects within the country during the reporting cycle
the list of domestic deaths during clinical trials should include at least the subject number, treatment plan (possibly still blind), and the cause of each subject's death If any safety issues are identified in the assessment of the death of the subject, it should be described in the "Overall Safety Assessment" in Section 18 of dSUR, as appropriate applicants can be prepared in accordance with Appendix R2 of the E2F DSUR Example Business Bidder If this format is used, please fill in the "Registration Number" (e.g CTR20XXXXXX) of the clinical trial under the Drug Clinical Trial Registration and Information Disclosure Platform under "Trial Number" a list of subjects who have withdrawn from clinical trials due to any adverse events in the reporting cycle
the list should include all subjects in the reporting cycle who have withdrawn from clinical trials due to any adverse events, whether or not drug-related If any security issues are identified in the assessment of the subject's withdrawal, they should be described in the DSUR Section 18 "Overall Security Assessment" as appropriate applicants can be prepared in accordance with Appendix R3 of the E2F DSUR Example Business Bidder If this format is used, please fill in the "Registration Number" of the clinical trial in the Drug Clinical Trial Registration and Information Disclosure Platform (e.g., CTR20XXXXXX) under "Trial Number" at the same time changes in drug clinical trial programs or new discoveries in clinical aspects, non-clinical or pharmaceutical changes or new findings in the reporting cycle
the applicant shall, in the form of a list, summarize changes in drug clinical trial scenarios, non-clinical or pharmaceutical changes, or new findings that occur during the reporting cycle, as shown in Schedule 1 for potentialincrease risks to the safety of subjects, the applicant shall summarize the acceptance number, application matters, date of hosting and approval of the supplemental application submitted in accordance with three categories: changes in pharmacy or new discoveries, non-clinical changes or new discoveries, changes in drug clinical trial scenarios or new discoveries in clinical areas No supporting information is required for the applicant's assessment that it does not affect the safety of the subject, the applicant shall summarize its contents, time, category and indicate the project number of the corresponding supporting information or the module and chapter number in the general technical document (CTD) of the general technical document for the application of the pharmaceutical registration in accordance with the changes in pharmacy or new discoveries, non-clinical changes or new discoveries, changes in drug clinical trial schemes or new discoveries in clinical aspects Applicants shall, in accordance with the requirements for the classification and declaration of chemical drugs, biological products and Traditional Chinese medicine registrations and declarations, CTD, etc., prepare the corresponding supporting information to be submitted together with DSUR For relevant information submitted during the reporting cycle (e.g., information for communication and communication, drug clinical trial program and supporting information submitted on the Drug Review Center website due to subsequent phased drug clinical trials), the submission path, time and reference number (e.g communication application number, etc.) should be indicated in the comments column, and no repeated submission sits changes in drug clinical trial scenarios or new discoveries in clinical aspects, non-clinical or pharmaceutical changes, or new findings ,
changes in pharmacy may increase the risk of safety of subjects1 Changes in pharmacy or new findings Supplementary application acceptance number Application date whether the application date is approved (yes/no/in review) 2 Non-clinical changes or new findings Supplementary application acceptance number Application Date Whether the application date is approved (yes/no/in review) 3 Changes in drug clinical trial programs or new discoveries in clinical aspects
Supplemental application number Application Seine Whether the application date is approved (yes/no/in review) II,
changes in pharmacy or new discovery category Summary of supporting information in the ct
D Date Category Summary Support information in the declaration material item number/in THE CTD module and chapter number notes 3 A brief summary of the drug clinical trial scenario change or new findings in the clinical aspects the category Content A brief summary of the supporting information in the declaration information project number / module and chapter number notes in the reporting materials the outline of the overall research plan for the next reporting cycle
the applicant shall provide the following: , the first, the next reporting cycle of the general plan for clinical research (i) the basis for the establishment of the topic; (ii) the indications to be studied; applicants should list the unlisted indications that are planned for the study during the next reporting cycle (iii) the overall path followed in evaluating the drug, briefly describe the order in which clinical trials are planned during the next reporting cycle, or a brief description of the patient population for the planned study (iv) the clinical trials to be conducted during the next reporting cycle, briefly describe the trial design of the clinical trials planned for the next reporting cycle (if no full-year plans are in place, applicants should indicate) (v) estimated the number of subjects; the estimated number of subjects in clinical trials planned for the next reporting cycle; and (vi) the estimated risk any significant or serious risks associated with drugs or related drugs are anticipated based on animal toxicology or previous human trials a summary of the master plan for non-clinical studies for the next reporting cycle
a brief description of new or continuing non-clinical studies planned for the next reporting cycle A summary of the general plan for pharmaceutical research in the next reporting cycle
a brief description of the new or continuing pharmaceutical research planned for the next reporting cycle.