Notice on Public Solicitation of "Guiding Principles for Evaluation of Immune-Related Adverse Events in Anti-tumor Therapy (Draft for Comment)"

Tumor immunotherapy is currently a hot spot in the development of new anti-tumor drugs.

In order to improve the scientificity and robustness of the determination of immune-related adverse events in clinical trials of anti-tumor therapy, improve the quality of safety data such as instructions, and strengthen the protection of patients participating in trials and post-marketing drugs, the industry has investigated and initially solicited expert opinions.

We sincerely welcome valuable comments and suggestions from all walks of life on the solicitation draft, and timely feedback to us for follow-up improvement

Please send your feedback to the mailbox of the following contact:

Contact: Lu Jun, Zhou Ming

Contact: lvj@cde.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

November 26, 2021

1 "Technical Guidelines for Evaluation of Immune-related Adverse Events in Anti-tumor Therapy (Draft for Solicitation of Comments)".