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2021 Annual Drug Evaluation Report Released - These issues are worth paying attention to

2021 Annual Drug Evaluation Report Released - These issues are worth paying attention to

On June 1, 2022, the State Food and Drug Administration issued the 2021 Annual Drug Evaluation Report (hereinafter referred to as the "Report"). The "Report" shows that China's drug review work in 2021 has achieved outstanding results, including the review of 47 innovative drugs throughout the year, setting a new record high; The overall time-bound completion rate increased to 98.93% throughout the year, and the time-bound completion rate of many projects made historic breakthroughs, including a number of new coronavirus vaccines, therapeutic drugs and innovative drugs, new drugs urgently needed overseas in clinical practice, and the launch of drugs for children.

2023-02-02

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

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

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).

2023-02-02

CDE Releases Annual Report on Clinical Trial Progress of New Drug Registration in China (2021)

CDE Releases Annual Report on Clinical Trial Progress of New Drug Registration in China (2021)

On June 7, 2022, CDE released the Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2021). Based on the registration information of the drug clinical trial registration and information disclosure platform, the report comprehensively summarizes and analyzes the status quo of new drug registration clinical trials in China in 2021, and compares and analyzes the changing trend characteristics in the past three years.

2023-02-02

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2021 Annual Drug Evaluation Report Released - These issues are worth paying attention to

2023-02-02

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

2023-02-02

CDE Releases Annual Report on Clinical Trial Progress of New Drug Registration in China (2021)

2023-02-02