By Fineline Cube 
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the “Technical Guidelines for Development Risk Management Plan (draft proposal)”, soliciting public feedback for one month. The guidelines aim to assist applicants in assessing clinical trial risks in a timely manner, implementing necessary control measures, and strictly enforcing drug safety responsibilities.
Purpose of DRMP
The drafting and continuous updating of the Development Risk Management Plan (DRMP) help applicants evaluate clinical trial risks promptly and take necessary control measures. Regulatory bodies can quickly obtain information on the applicant’s risk identification and control measures through the DRMP, and assess whether the control measures are sufficient.
Content of the Guidelines
The document consists of five chapters, providing a detailed introduction to the principles, general considerations, and main content of DRMP writing for innovative drugs. Templates are also provided for reference during writing, including an overview of drug basic information, safety, drug vigilance activities, and risk control measures. Applicants can choose to write the DRMP based on active ingredients (traditional Chinese medicine based on prescription), indications, or clinical trials according to the characteristics of the investigational drug and internal management status.-Fineline Info & Tech