By Fineline Cube 
The Center for Drug Evaluation (CDE) is seeking industry feedback on the 103rd batch of chemical generic reference preparations, a key regulatory step affecting generic drug development and approval pathways in China. The latest list includes new specifications, information updates, and products that failed regulatory review.
Regulatory Update & List Composition
| Category | Quantity | Status |
|---|---|---|
| New Specifications | 11 | Yet to be launched in China |
| Information Updates | 15 | Added for new information |
| Failed Review | 9 | Did not meet criteria |
Key Implications for Market
- Generic Pipeline: 11 new specifications provide reference standards for upcoming generic approvals, accelerating development timelines
- Information Updates: 15 updated specs reflect evolving quality standards and bioequivalence requirements
- Failed Reviews: 9 failures highlight stringent CDE quality bar, potentially delaying affected generic programs
- Industry Impact: Reference preparation lists are critical for generic manufacturers; changes affect ¥200 billion+ annual generic market
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory feedback timelines and market impacts of CDE reference preparation updates. Actual outcomes may differ due to regulatory interpretation and industry response patterns.-Fineline Info & Tech