T/CGCPU 016-2021 Pediatric clinical trial technical requirements for new oral inhalation pharmaceutical preparations

Scope

Scope: This technical requirement aims to provide technical guidance in terms of overall planning, protocol design, organization and implementation, and data analysis for applicants seeking drug registration and researchers conducting clinical trials of oral inhalation formulations in pediatric patients with respiratory diseases, so as to accurately evaluate the safety and efficacy of the drug under development. The scope of new drugs includes Class I innovative drugs and Class II modified innovative drugs in the registration classification of chemical drugs. This technical requirement only provides references and suggestions on the technical aspects of clinical trials of oral inhalation formulations, excluding nasal, oral, injectable, or other formulations. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 4. Basic methods of clinical trials 4.1 Innovative drugs not yet marketed domestically or abroad (Class I) 4.2 Modified new drugs not yet marketed domestically or abroad (Class II) 5. Preparation materials before the start of clinical trials 5.1 Investigator's brochure 5.2 Clinical study protocol 5.3 Informed consent form 5.4 Case report form 6. Overall considerations for clinical trials of oral inhalation formulations for respiratory diseases 6.1 Purpose of the trial 6.2 Age selection 6.3 Case selection 6.4 Completion and withdrawal criteria 6.5 Treatment regimen 6.6 Efficacy evaluation 6.7 Safety evaluation 6.8 Ethical considerations 6.9 Data management and statistical analysis Appendix A (informative appendix): Materials required to be prepared before clinical trials Appendix B (informative appendix): Classification of age groups in pediatric populations Appendix C (informative appendix): Common respiratory diseases and diagnostic criteria in children Appendix D (informative appendix): Classification of datasets Appendix E (informative appendix): Bacte

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