On the evening of May 6th, CDE released the "Technical Guidelines for Writing Risk Management Plans during Innovative Drug Development (Draft for Comments)".

The Development Risk Management Plan (DRMP) during the development of innovative drugs is an important document during clinical trials. Its purpose is to strengthen the monitoring, identification, evaluation, and control of safety signals during the implementation of innovative drug clinical trials, take risk minimization measures, and ensure the safety of subjects.

To guide applicants in writing risk management plans for innovative drug development in a standardized manner, the Drug Review Center has organized the drafting of the "Technical Guidelines for Writing Risk Management Plans for Innovative Drug Development". After internal discussions within the center, a draft for soliciting opinions has been formed.

We sincerely welcome valuable opinions and suggestions from all sectors of society on the draft for soliciting opinions, and provide timely feedback to us for future improvement. The deadline for soliciting opinions is one month from the date of publication.