Technical Guidelines on CMC Study and Evaluation of Oncolytic Virus Products (Trial)
Request Technical Guidelines on CMC Study and Evaluation of Oncolytic Virus Products (Trial)
  • Local Title:溶瘤病毒产品药学研究与评价技术指导原则(试行)
  • 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
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ZH Official 溶瘤病毒产品药学研究与评价技术指导原则(试行) Download
Summary

Based on the current technology development and scientific knowledge, the Guidelines provides advice and general technical requirements for CMC study on oncolytic virus products. 

Whether the Guidelines applies to a specific product depends on specific conditions. During the product development, stakeholders can adopt other more suitable or effective methods according to the specific conditions of product development. But the methods must obey the law for drug development and the stakeholders should provide scientific and reasonable evidence. 

The Guidelines mainly targets CMC study for products seeking marketing authorization. But it can also be a reference for stakeholders who conduct CMC study that is adapted to the aim and characteristics of the clinical trial.