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CDE issued three guiding principles, including the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial).

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Release time：2023-02-02

On May 31, 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration issued three pharmaceutical guidelines: "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems (Trial)", "Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial)", and "Technical

Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)", all of which came into force on the date of promulgation (May 26, 2022).

Related attachments:

1. Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification System (Trial) Full text download: https://www.cde.org.cn/main/news/viewInfoCommon/6f14372f020446361601bb074a09410d

2. Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial) Download the full text: https://www.cde.org.cn/main/news/viewInfoCommon/0584963a84e01bb4d83022f559d22144

3. Download the full text of "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)": https://www.cde.org.cn/main/news/viewInfoCommon/c0ec5e347ba84df67bf75e15f6ad3f3f

key words： CDE issued three guiding principles, including the Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial).

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