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.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

September 18, 2021

Relevant attachments

1	Draft of Technical Guidelines for Clinical Risk Management Plan for Application of Chimeric Antigen Receptor T Cell (CAR-T) Cell Therapy Products. pdf
2	Drafting instructions. pdf
3	Feedback form for soliciting opinions. docx

1 chimeric T cell antigen receptor (CAR-T) cell therapy products listed declaration clinical risk management plan draft technical guidelines .
pdf 2 drafting notes .
pdf 3 solicit feedback form .
docx a chimeric antigen receptor T cells (CAR-T) Cell Therapy Product Application and Marketing Clinical Risk Management Plan Technical Guiding Principles Draft.
pdf 1 Chimeric Antigen Receptor T Cell (CAR-T) Cell Therapy Product Application and Marketing Clinical Risk Management Plan Technical Guiding Principles Draft for Comment .
pdf chimeric T cell antigen receptor (CAR-T) cell therapy products listed declaration clinical risk management plan draft technical guidelines .
pdf 2 drafting notes .
pdf 2 drafting notes .
pdf drafting instructions .
pdf 3 comments feedback Form .
docx 3 Feedback form for soliciting opinions.
docx Feedback form for soliciting opinions.
docx