Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment period titled, “Safety Information Assessment and Risk Management Work Procedures.” It outlines the agency’s expectations for the monitoring, identification, evaluation, control, and communication of safety risks during clinical trials conducted in China.

According to the public notice, the Center for Drug Evaluation implemented internal changes in January 2021 that have been evaluated and are now being published in draft form for public comment. The draft release includes a document listing the revisions and the draft for comment.

The “Revision Explanation” document includes background information and seven “amendments” that list the changes being proposed in the draft. The changes are a mixture of internal agency requirements and industry requirements, summarized here:

• Clarification of the responsibilities of the Center for Drug Evaluation Clinical Trial Management Office
• Clarification of risk management notification
• The addition of “emergency prevention and control drugs”
• Content of “expert consultation meeting”
• Content of risk communications
• Adjustment of “the working time limit in Annex 2”
• Amendments to other terminology, such as changing “applicant” to “sponsor”

The “Draft for Solicitation of Comments” is the draft document released for comment, which includes five chapters and eight attachments:

• Chapter I General Provisions
• Chapter II Responsibilities and Division of Labor (Clinical Trial Management Office, review department)
• Chapter III Working Procedures for Safety Information Monitoring Evaluation, and Risk Management
  • Safety Risk Management During Clinical Trials
  • Review process of Clinical Trial Management Office, review by the Review Department
• Chapter IV Risk Communication
• Chapter V Others (includes timelines for reporting safety signals)

Attachments:

1. Flow chart of safety risk management system during clinical trials
2. Table of “Working Time Frame of Safety Report (Information) in Risk Management System
3. Notification letter on Risk Management of Clinical Trials of XX (Drug name)
4. Clinical trial risk control notification
5. Suspension of Clinical Trial Notice
6. Notice of Termination of Clinical Trial
7. Resumption of Clinical Trial Notification
8. Continue to Suspend Clinical Trial Notification