Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)

Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related adverse events, improve the quality of instruction writing, and effectively ensure the safety of patient medication is an urgent problem that regulators and the industry need to solve. Under the deployment of the National Medical Products Administration, the Drug Review Center organized the formulation of the "Technical Guidelines for the Evaluation of Immune-Related Adverse Events in Anti-tumor Therapy" (see attachment).

According to the requirements of the "Notice of the General Office of the National Medical Products Administration on the Issuance of the Procedure for the Release of Technical Guidelines for Drugs" (Drug Supervision General Drug Administration [2020] No. 9), after review and approval by the National Medical Products Administration, it is now issued and will be implemented from the date of issuance.

This is hereby announced.

Attachment: Technical Guidelines for the Evaluation of Immune-Related Adverse Events in Anti-tumor Therapy

Drug Review Center of the National Medical Products Administration

May 17, 2022

Specific news link: Notice of the Center for Drug Evaluation of the National Medical Products Administration on the release of the "Technical Guidelines for the Evaluation of Immune-Related Adverse Events of Anti-tumor Therapy" (No. 25 of 2022)