On Sept. 6, 2023, China’s Center for Drug Evaluation (CDE) released the 2022 China Drug Evaluation Report.
ChemLinked BaiPharm Team selected excerpts from the report to help stakeholders learn about China’s drug review & approval data and the reforms of its drug regulatory system.
To download the report, 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 for innovator drugs
1.3 Accepted applications for improved new drugs
1.4 Accepted TCM applications requiring technical review
1.5 Accepted chemical drug applications requiring technical review
1.6 Accepted biological product applications requiring technical review
Part 2 Review of Applications
Part 3 Approval of Applications
3.1 Overview of approval / recommended approval
3.2 Approval / recommended approval of innovator drug applications
3.3 Approval / recommended approval of TCM applications
3.3.1 Overview
3.3.2 Approved TCM IND applications
3.3.3 Recommended-to-be-approved TCM NDAs
3.4 Approval / recommended approval of chemical drug applications
3.4.1 Overview
3.4.2 Approved chemical drug IND applications
3.4.3 Recommended-to-be-approved chemical drug NDAs
3.4.4 Equivalence applications for chemical drugs
3.5 Approval / recommended approval of biological product applications
3.5.1 Overview
3.5.2 Approved IND applications for prophylactic biologics
3.5.3 Recommended-to-be-approved NDAs for prophylactic biologics
3.5.4 Approved IND applications for therapeutic biologics
3.5.5 Recommended-to-be-approved NDAs for therapeutic biologics
3.5.6 Indications of approved biological IND applications
3.5.7 Indications of recommended-to-be-approved biological applications
Part 4 Expedited Program
4.1 Breakthrough therapy designation (BTD)
4.2 Conditional approval (CA)
4.3 Priority review (PR)
4.3.1 Applications admitted into priority review
4.3.2 Applications recommended to be approved via priority review
4.4 Special approval
Part 5 Communication with CDE
5.1 Communication between CDE and applicants: functions and forms
5.2 Meeting applications received and processed by CDE
5.3 Meetings held by CDE
Part 6 Onsite Inspection
Part 7 Drug Products Approved for Major Therapeutic Areas
7.1 Vaccine/drug for COVID-19
7.2 New TCM
7.3 Rare disease drug
7.4 Pediatric drug
7.5 Drug for public health
7.6 Anticancer drug
7.7 Circulatory system drug
7.8 Respiratory system drug
7.9 Gastrointestinal drug
7.10 Renal/urinary system drug
7.11 Anti-infective drug
7.12 Endocrine drug
7.13 Blood system drug
7.14 Autoimmune and immunosuppressant drug
7.15 Nervous system drug
7.16 Dermatological, ophthalmological, and otorhinolaryngological drug
Part 8 Reasons for Disapproval and Analysis of Deficiencies in Drug Registration Applications
8.1 Overview of disapproval / recommended disapproval
8.2 Main problems
8.2.1 Problems in R&D project establishment
8.2.2 Problems regarding effectiveness
8.2.3 Problems regarding safety
8.2.4 Problems in quality controllability
8.2.5 Problems in other aspects
8.3 Comparison with previous years
8.3.1 Similarities
8.3.2 Changes in problems
8.4 Advice from CDE
8.4.1 Providing sufficient evidence for establishing a drug R&D project
8.4.2 Establishing and adhering to scientific logic of innovative drug development
8.4.3 Making use of the communication mechanism
8.4.4 Studying laws, regulations, and technical guidelines
Part 9 Deepening the reform of drug review & approval system
9.1 Accelerating marketing authorization of new drugs
9.2 Harnessing the expedited programs
9.3 Encouraging pediatric drug development
9.4 Stepping up equivalence evaluations
9.5 Strengthening the safety of clinical trials
9.6 Promoting eCTD submission
9.7 Facilitating early resolution of drug patent disputes
PREVIEW
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