On June 1, China Center for Drug Evaluation (CDE) released the 2021 China Drug Evaluation Report. ChemLinked BaiPharm Team selected excerpts from the report to help pharmaceutical companies understand the data and reform trends of China\’s drug review and approval.

ChemLinked BaiPharm Report contains the significant data of drug evaluation. The report can be downloaded for free at the bottom of this page.

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

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

To see the preview or download the report, please [read full content].

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If you have any questions about pharmaceutical regulatory compliance in China, please feel free to contact us.

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