Center for Drug Evaluation (CDE) of China published a guideline document pertaining to “Clinical Trial Safety Information Evaluation and Management Standards (Pilot)” (No. 5 in 2020). The guidance document which is applicable for drug sponsors clarifies the responsibilities of the parties with respect to risk management and safety information reporting. The implementation of the guidance document shall be effective from 01 July 2020.
The document also emphasizes that the sponsors establish cooperation with institutions and relevant parties to achieve their objectives in terms of risk management and safety. In order to execute risk monitoring, identification, assessment, and control, a pharmacovigilance system should be implemented by drug sponsors to discover any pertinent issues on safety and risks. Drug sponsors shall also proactively pursue risk management in terms of modifying the clinical trial protocols or terminate and suspend the clinical trials itself.
In the event there is any safety risks discovered in the clinical trial by CDE, applicants will be required to take further measures to control risk which includes steps as modifying clinical trial, investigator’s manual, or safety update reporting period during research and development. Applicants will also receive a clinical trial risk control notice upon which effective steps shall be taken in a prompt manner and applicants shall be required to report the progress and completion to the website of CDE within a period of 20 working days.
There are 2 important changes:-
1. Article 4 mentioned that the only submission pathway would be through Pharmacovigilance electronic transfer system; the former Applicant window was not mentioned in this revision.
2. Appendix 1 mentioned that failure to submit the SUSAR report, DSUR, or other potentially serious safety risk information report to the regulatory agency in a timely manner within the stipulated time in accordance with the relevant requirements may lead to suspension of clinical trials.
More information pertaining to the document could be obtained here:-