The National Health Commission (NHC) has released the “Somatic Cell Clinical Research Guidelines (draft proposal)” and is soliciting public feedback until May 24, 2023. These guidelines are designed to provide direction for companies and institutions engaged in clinical trials that do not seek formal market approval, which would otherwise necessitate a filing with the National Medical Products Administration. The focus is on entities conducting early clinical exploration phases of cell therapy to address scientific inquiries or verify hypotheses.
Guidance for Non-Drug Registration Clinical Research
The Guidelines outline requirements and offer guidance for medical institutions undertaking somatic cell clinical research initiated by researchers for purposes other than drug registration. This includes management procedures, technical requirements, and relevant materials necessary for conducting such research.
Scope of Research and Key Considerations
The research scope encompassed by these Guidelines includes a comprehensive evaluation of somatic cell preparations, covering toxicity, safety, abnormal immune responses, tumorigenicity, and pharmacokinetic and pharmacodynamic properties. By establishing a framework for these early-phase trials, the NHC aims to ensure the safety and efficacy of somatic cell therapies while fostering scientific advancement in this field.-Fineline Info & Tech
