By Fineline Cube 
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the 102nd List of Reference Preparations (RLDs) for Chemical Generic Drugs (draft for public comment), which will remain open for review until January 16, 2026. The list includes 9 new drug specifications, 20 supplemental additions, and 14 specifications that failed review due to insufficient safety and efficacy data.
List Summary
| Category | Count | Status |
|---|---|---|
| New Inclusions | 9 specifications | First‑time entry into RLD list |
| Supplemental Additions | 20 specifications | Added to existing RLD entries |
| Failed Review | 14 specifications | Rejected due to inadequate safety/efficacy data |
| Public Comment Period | Jan 5 – Jan 16, 2026 | Draft open for stakeholder feedback |
Regulatory Context & Market Impact
Reference Preparations List: The RLD list identifies innovator products and benchmark generics that serve as bioequivalence standards for domestic manufacturers seeking generic drug approval in China.
Key Implications:
- New Inclusions (9 specs): Create immediate opportunities for domestic generic manufacturers to develop copycat versions of previously unreferenced drugs, potentially reducing costs and expanding patient access
- Supplemental Additions (20 specs): Clarify and expand existing RLD entries, streamlining the development pathway for complex generics (e.g., extended‑release formulations)
- Failed Review (14 specs): Highlights NMPA’s tightening standards for safety and efficacy data, raising the bar for future RLD submissions
Market Size: Each new RLD inclusion can unlock a ¥200‑500 million (US$28‑70 million) generic market opportunity within 2‑3 years of approval.
Failed Review Analysis
Primary Reasons for Rejection:
- Insufficient clinical data: Lack of robust Phase III trials in Chinese populations
- Safety concerns: Unresolved adverse event signals in post‑marketing surveillance
- Efficacy gaps: Non‑inferiority margins not met vs. international reference standards
Therapeutic Areas Affected: Primarily cardiovascular, CNS, and anti‑infective drugs, where safety margins are particularly stringent.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the finalization of the 102nd RLD list, its impact on generic drug development timelines, and market opportunities for domestic manufacturers. Actual results may differ materially due to public comment feedback, regulatory review adjustments, and competitive dynamics in the generic drug sector.-Fineline Info & Tech