By Fineline Cube 
China’s Center for Drug Evaluation (CDE) announced it is seeking public feedback on the 101st batch of reference standards for chemical generic drugs, marking a critical regulatory milestone for China’s generic pharmaceutical industry with 74 total specifications under review.
Regulatory Consultation Details
| Attribute | Details |
|---|---|
| Regulatory Authority | Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA) |
| Consultation Type | Public feedback on reference standards |
| **Batch Number | 101st batch |
| **Release Date | 19 Dec 2025 |
| **Feedback Period | Standard 30-day public comment period |
Draft List Breakdown
| Category | Count | Status |
|---|---|---|
| New Drug Specifications | 38 | Never previously published |
| Supplementary Specifications | 11 | Additional information for existing published standards |
| Failed Specifications | 25 | Did not pass CDE review |
Market Context & Strategic Implications
Reference Standards Importance:
- Quality Benchmark: Sets official analytical and testing standards for generic drug approvals
- Approval Gateway: Generics manufacturers must demonstrate bioequivalence to these standards
- Market Access: New standards enable faster generic entry, increasing competition and reducing prices
Key Implications:
- 38 new specifications will open pathways for generic versions of previously unstandardized drugs
- 11 supplementary specs will clarify testing requirements for existing generics, potentially accelerating approvals
- 25 failures indicate rising quality thresholds, weeding out substandard applications
Industry Impact:
- Generic Drug Market: China’s generic market valued at ¥800 billion (US$110 billion); reference standards directly impact 30% of pipeline applications
- Manufacturers: Local generic companies must reformulate products to meet new standards; international players gain clarity for China entry
- Timeline: Final standards expected Q1 2026 after public consultation; implementation within six months
Forward‑Looking Statements
This brief contains forward‑looking statements regarding CDE’s standard finalization timeline and its impact on generic drug approvals. Actual implementation may differ based on public feedback and regulatory review.-Fineline Info & Tech