Notice on Publicly Soliciting Opinions on "Chimeric Antigen Receptor T Cell (CAR-T) Product Application and Marketing Clinical Risk Management Plan Technical Guidelines (Draft for Solicitation of Comments)"

Chimeric antigen receptor T cell therapy products have the characteristics of novelty, complexity and technical specificity.
With the development of such products and the successive application for listing, it will promote the early detection of the risks of such products and provide effective risks.
Minimal measures to ensure that the safety risk is controllable after listing, and it is necessary to put forward requirements and provide guidance on the clinical risk management plan for applying for listing
.
Our center drafted the "Technical Guidelines for the Clinical Risk Management Plan for the Application and Marketing of Chimeric Antigen Receptor T Cells (CAR-T) Products (Draft for Comment)" on the basis of full investigation
.

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
.
The time limit for soliciting opinions is 1 month from the date of publication
.

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

Contact: Huang Yunhong, Zhao Chenyang

Contact: huangyh@cde.
org.
cn, zhaocy@cde.
org.
cn

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

September 18, 2021

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