临床试验用药品生产质量管理的初步探讨

Preliminary discussion about good manufacturing practice for investigational medicinal products

本文借鉴国外法规的具体指导原则,结合国内临床试验用药品生产质量管理的特点与现状,深入分析了临床试验用药品生产质量管理的问题,阐明生产质量的关注要点,并给出实践的建议措施,以期为新药研究者提供参考,旨在促进临床试验用药品生产质量管理水平,保护临床受试者的权益,保障临床试验的质量。

Taking the specific guiding principles of foreign regulations as reference,combined with the domestic situations,this paper analyzed the problems of good manufacturing practice for investigational medicinal products and give practical suggestions on the quality of investigational medicinal products,in addition to providing a reference for new drug researchers,this paper also aimed to promote the quality management level of drugs for clinical trials,protect the rights of clinical patients,and ensure the quality of clinical trials.