Medical Policies Weekly

(1) "Technical Guidelines for Clinical Pharmacology Research of Innovative Drugs (Draft for Comments)": The guidelines mainly focus on the pre-marketing clinical pharmacology research related issues of innovative drugs, and aim to provide suggestions for key issues such as the research content, research timing, and overall design of clinical pharmacology research in the development of innovative drugs. The main content includes the introduction, the purpose and role of the clinical pharmacology research of innovative drugs, the overall clinical pharmacology research plan, the content and timing of the research, the research methods, the overall considerations of the research design, the basic considerations of the innovative chemical drugs and the innovative drugs of biological products, regulatory considerations.

(2) "Guidelines for Drug Clinical Trial Data Management and Statistical Analysis Plans (Draft for Comments)": The first is preface, which firstly explains the role of data management plans and statistical analysis plans in clinical trials, and then leads to the drafting purpose of the guidelines; the second part is the data management plan, which introduces the definition and basic content of the data management plan, including test overview, data management process and data flow, collection/management system, data management steps and tasks, and quality control; part three is the statistical analysis plan, which introduces the definition and basic content of the statistical analysis plan, including the summary of the experiment, the estimation target, the sample size, the analysis data set, the statistical analysis method, the consideration of multiplicity and the interim analysis; the fourth part is the reference.

(3) "Technical Guidelines for Clinical Trials of Novel Coronavirus Pneumonia Antiviral Treatment and Prevention of New Drugs (Trial) (Draft for Comments)": The first part is an overview, mainly introducing the background, positioning, purpose and scope of application of the guidelines, as well as the epidemiological characteristics, clinical manifestations of the disease, and current treatment options of new coronavirus viral pneumonia; the second part is early clinical trials, mainly explaining and recommending the design of phase I clinical trials; the third part is exploratory clinical trials, mainly explain and design the phase II clinical trial design, purpose, population, main efficacy endpoints, etc.; the fourth part is a confirmatory clinical trial, divided into two parts: therapeutic research and preventive research, focusing on the research design, population, dosing schedule and dosing cycle, efficacy endpoints, evaluation and follow-up time, safety indicators and risk control, and statistical considerations of phaseⅢconfirmatory clinical trials of new coronavirus pneumonia antiviral drug.

(4) "Procedures and requirements for filing changes of overseas-produced drugs after marketing (draft for comments)”: It mainly clarifies the application scope, working procedures, requirements and review time limits for changes of overseas-produced drugs after marketing. The scope of application is only for overseas post-marketing application for registration changes of manufactured drugs; the working procedures refine the applicant's handling procedures and related requirements, including electronic submission methods, data submission requirements, etc., and clarify that the review time limit for changes in the registration of overseas manufactured drugs is 60 working days; It is clarified that if there is any objection to the content of the record after review, the publicity information of the “Publicity of Recording Information of Overseas Produced Drugs” will be revised on the website of the National Bureau.

(5) "Technical Guidelines for Drug Non-clinical Dependence Research (Draft for Comments)": The guidelines introduce the stratification strategy for the evaluation of dependence potential and the content of early evaluation of dependence potential, focusing on the basics of animal dependence behavioral experiments. The requirements include the general principles of the test, the test substance, the experimental animal, the dosage, the route of administration, the control group, the index detection time, the general requirements of each test, etc. The guidelines apply to the evaluation and research of the non-clinical dependence potential of Chinese medicines and chemical drugs.

(6) "Guidelines for the Design of Clinical Trials of Liraglutide for Weight Management (Draft for Comments)": The first part is an overview, explaining the background, main purpose and scope of application of the guidelines; the second part is the requirements for clinical research, which introduces the sequence of clinical research and development of liraglutide in the development of weight management indications, and provides suggestions on the impact of different clinical practices at home and abroad on the design; the third part is the key points of clinical trial design, the trial design, study population, dosing regimen , The main endpoints and evaluation, research period, sample size and other issues are explained item by item.

(7) "ICH E18 and M3 (R2) and Questions and Answers (R2) Guiding Principles Transformation Implementation Suggestions" for comments: "E18: Genome Sampling and Genome Data Management Guidelines", 6 months after the announcement, sampling and genomic data management are applicable to E18, and the requirements of the "Regulations on the Management of Human Genetic Resources of the People's Republic of China" shall be followed during the implementation process; "M3 (R2) and Questions and Answers (R2): Guiding principles and questions and answers for non-clinical safety research to support clinical trials and marketing of drugs ", since the date of the announcement, non-clinical safety studies are applicable to M3 (R2) and question and answer (R2).

(8) "Technical guidelines for clinical single and multiple dose escalation pharmacokinetic research of chemical drug innovative drugs (draft for comments)": the main content includes: the preface, introducing the background and purpose of the drafting of the guidelines, and the scope of application; the overall consideration part, which explains the main content and the significance of each content in the clinical single and multiple dose escalation pharmacokinetic studies; the research design part, which explains the clinical single and multiple dose escalation specific research design considerations for pharmacokinetic studies, including the subject population, sample size, dose selection, sampling design, testing substances, consideration of other influencing factors, etc.; the data section describes the requirements for the estimation of pharmacokinetic parameters, dose-exposure relationship analysis and summary analysis of multiple research data; the research report part describes the matters that should be paid attention to when writing the research report.

(9) "Guiding Principles for the Application of Patient Report Outcomes in Drug Clinical Research (Draft for Comments)": Main contents include introduction, definition of patient report outcome, development, translation, and improvement of patient report outcome measurement scale, selection and evaluation of patient report outcome measurement scales, consideration of using patient report outcomes in clinical research, electronic patient report outcomes, and communication with review institutions. The guiding principles apply to clinical research for the purpose of drug registration, including clinical trials and real-world studies, and use patient-reported outcome (PRO) data as the primary or key secondary endpoint to support drug review decisions.