On February 8, 2024, China's Center for Drug Evaluation (CDE) published the 2023 Drug Evaluation Report. According to the report, in 2023, NMPA granted approval to a total of 40 first-class innovative drugs, including:
9 drugs approved through priority review.
13 drugs granted conditional approval.
8 drugs granted breakthrough therapy designation during clinical studies.
4 drugs granted special approval for the treatment of COVID-19.
Furthermore, NMPA approved 45 drugs for rare diseases, 92 pediatric drugs, and 3 CAR-T therapeutic products last year.
ChemLinked BaiPharm Team has selected excerpts from the report and translated them into English. To access the translated version, please click the download button at the end of this article.
Contents
Part 1 Acceptance of Applications
1.1 Overview of accepted applications
1.2 Accepted applications subject to technical review
1.2.1 Accepted TCM applications subject to technical review
1.2.2 Accepted chemical drug applications requiring technical review
1.2.3 Accepted biological product applications subject to technical review
1.3 Accepted applications subject to direct administrative review
Part 2 Review and Approval of Applications
2.1 Overview of reviewed and approved applications
2.1.1 Reviewed applications subject to technical review
2.1.2 Highlighted approvals
2.2 Review, approval, and recommended approval of TCM registration applications
2.2.1 Review conclusions of TCM registration applications
2.2.2 Approved or recommended-to-be-approved TCM registration applications
2.3 Review, approval, and recommended approval of chemical drug registration applications
2.3.1 Review conclusions of chemical drug registration applications
2.3.2 Approved chemical drug IND applications and recommended-to-be-approved NDAs
2.3.3 Recommended-to-be-approved chemical drug ANDAs
2.3.4 Equivalence applications for chemical drugs
2.4 Review, approval, and recommended approval of biological product applications
2.4.1 Review conclusions of biological product applications
2.4.2 Approved IND applications and recommended-to-be-approved NDAs for prophylactic biologics
2.4.3 Approved IND applications and recommended-to-be-approved NDAs for therapeutic biologics
2.5 Review and approval of applications subject to direct administrative review
Part 3 Expedited Program
3.1 Breakthrough therapy designation (BTD)
3.2 Conditional approval (CA)
3.3 Priority review (PR)
Part 4 Communication and Exchanges with CDE
4.1 Communication, exchange, and meeting applications received and handled by the CDE
4.2 General technical issue query
Part 5 Improvement of Drug Regulatory System
Preview
