Technical Guidelines on Clinical Research and Development of New Drugs for Acute Myeloid Leukemia (AML)
Request Technical Guidelines on Clinical Research and Development of New Drugs for Acute Myeloid Leukemia (AML)
  • Local Title:急性髓系白血病新药临床研发技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Drug Evaluation (CDE)
  • Type:Guideline
  • Status:In force
  • Release Date:2023-02-13
  • Implementation Date:2023-02-13
Document
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ZH Official 急性髓系白血病新药临床研发技术指导原则 Download
Summary

Based on current clinical practices, the Technical Guidelines is about the threads for thought and specific elements in designing the clinical research on new drugs for acute myeloid leukemia (AML). 

The Technical Guidelines only represents CDE's current opinions. Some contents in the Technical Guidelines may not be adopted because of the changes of clinical practice. Therefore, the Technical Guidelines is a reference for drug applicants and investigators with no legal effects. While applying the Techncial Guidelines into practice, applicants and investigators should also refer to ICH's guidelines and other technical guidelines issued in or outside China.