Notice of public consultation on the Technical Guidelines for Communication and Communication of Anti-Tumor Innovative Drugs Registered in Single Arm Trials for Access to Key Pre-Trial Clinical Aspects

notice on the public request for opinions on the Technical Guidelines for Communication and Communication of Anti-Tumor Innovative Drugs registered in single-arm trials before entering key trials
: 2020522, in accordance with Article 16 of the Drug Registration Management Measures (State Administration of Market Supervision and Administration, No27), applicants may communicate with major technical institutions such as the Drug Review Center at key stages such as the application for drug clinical trials, drug clinical trials and before the application for drug listing licensesin order to encourage innovation, help applicants better prepare for communication, ensure that anti-tumor innovative drugs with sufficient scientific basis to carry out key single arm trials, chemical medicine clinical a relevant indications group organization wrote the "one-arm test support registered anti-tumor innovative drugs into the key clinical aspects of communication technical guidelines (draft for comments)These guidelines apply to innovative anti-tumor therapeutic drugs and do not cover cell therapy and gene therapy productswe sincerely welcome all sectors of the community to the draft of the request for comments and suggestions, and timely feedback to us, in order to follow up the improvementThe time limit for soliciting opinions is one month from the date of publicationyour feedback please send your feedback to the following contacts:Contact: Tang Ling, Zhao Xiao
Contact: tangl@cde.org.cn, zhaox@cde.org.cn
thank you for your participation and strong supportThe Drug Review Centre of the National Drug Administration22 May 2020