mp.weixin.qq.com· 中肽生化·· 7 hours agoPickScore60
China's CDE Issues Clinical Trial Guidance for Obstructive Sleep Apnea Drugs
政策法规 | 国家药监局药审中心发布《阻塞性睡眠呼吸暂停治疗药物临床试验技术指导原则》
In brief
China's Center for Drug Evaluation, under the National Medical Products Administration, has issued the Technical Guidance Principles for Clinical Trials of Drugs for the Treatment of Obstructive Sleep Apnea, aiming to improve the quality and efficiency of drug development in this indication. The guidance was reviewed and approved by the National Medical Products Administration and takes effect on the date of issue. Sponsors developing obstructive sleep apnea therapies in China can now design trials against this framework.
Why it matters
New CDE clinical trial guidance defines the regulatory path for obstructive sleep apnea drug development in China.
Source: mp.weixin.qq.com · mp.weixin.qq.com