REPORT

2021 China CDE Drug Evaluation Report

by Grace Wang
Jul 04, 2022

On June 1, China Center for Drug Evaluation (CDE) released the 2021 China Drug Evaluation Report

In 2021, CDE approved 47 innovator drugs which have new ingredients not previously approved in China. In response to COVID-19 pandemic, CDE approved 3 vaccines and 5 drugs, including the amubarvimab/romlusevimab combination therapy. 

For more detailed information, please download the report for free at the bottom of this page.

Report Contents

1. Acceptance of Applications

1.1 Overview of Applications

1.2 Acceptance of Innovator Drug Applications

1.3 Accepted TCM Applications Requiring Technical Review

1.4 Accepted Chemical Drug Applications Requiring Technical Review

1.5 Accepted Biological Product Applications Requiring Technical Review

2. Review of Applications

3. Approval of Applications

3.1 Overview of Approval/Recommended Approval

3.2 Approval of Innovator Drug Applications

3.3 Approval/Recommended Approval of TCM Applications

3.4 Approval/Recommended Approval of Chemical Drug Applications

3.5 Approval/Recommended Approval of Biological Product Applications

4. Expedited Approval

4.1 Breakthrough Therapy Designation (BTD)

4.2 Conditional Approval (CA)

4.3 Priority Review (PR)

4.4 Special Approval (SA)

5. Onsite Inspections

6. Medical Products in Significant Therapeutic Areas

6.1 Vaccines and drugs for COVID-19

6.2 New TCMs

6.3 Rare disease (orphan) drugs

6.4 Pediatric drugs

6.5 Vaccines for public health

6.6 Anti-neoplastic drugs

6.7 Anti-infection drugs

6.8 Endocrine system drugs

6.9 Circulatory system drugs

6.10 Blood system drugs

6.11 Autoimmune and immunosuppressant drugs

6.12 Dermatological, ophthalmological and otorhinolaryngological drugs

7. Disapproval Reasons

7.1 R&D Problems

7.2 Efficacy Problems

7.3 Safety Problems

7.4 Problems in Quality Controllability

7.5 Compliance Problems

7.6 Other Problems

8. Reforms of the Drug Review & Approval System

8.1 Promoting Pediatric Drugs' Innovative Development

8.2 Improving Clinical Trial Administration and Clinical Research Quality

8.3 Establishing China Marketed Drug Patent Registration Platform

8.4 Stepping Up Quality and Therapeutic Equivalence Evaluations

8.5 Improving Transparency in Drug Review and Approval

8.6 Driving the Digitalization of Drug Applications

Preview

center-for-drug-evaluation-2021-china-drug-evaluation-report-1.pngCenter for Drug Evaluation (CDE): 2021 China Drug Evaluation Report, Page 1center-for-drug-evaluation-2021-china-drug-evaluation-report-2.pngCDE: 2021 China Drug Evaluation Report, Page 2center-for-drug-evaluation-2021-china-drug-evaluation-report-3.pngCDE: China Drug Evaluation Report, Page 3

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Grace Wang
ChemLinked Regulatory Analyst
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