Question: ArrayDoes it mean that the preparation of experimental drugs should comply with the relevant requirements for quality management of clinical trial drug production? (GCP No. 57 of 2020, Article 44 (1)) @ @ Please refer to the "Good Manufacturing Practice for Clinical Trial Drugs (Draft for Soliciting Opinions)" released by NMPA in July 2018, and look forward to the introduction of formal regulations.
Answer:
参见2018年7月NMPA发布的《临床试验用药品生产质量管理规范(征求意见稿)》,并期待正式法规的出台。