The National Medical Products Administration (NMPA) has released the 110th batch of the Catalog of Reference Listed Drugs (RLD) for Chemical Generic Drugs, adding 28 new drug specifications and providing supplementary information for 27 drug specifications from previous batches. The update further extends the reference standard against which generic chemical drug applicants in China demonstrate consistency with originator products.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Document | Catalog of Reference Listed Drugs (RLD) for Chemical Generic Drugs – 110th Batch |
| Release Date | 19 Oct 2026 |
| New Additions | 28 drug specifications |
| Supplementary Updates | 27 drug specifications from previous batches |
| Scope | Chemical generic drugs |
| Next Steps | Not disclosed |
Policy Context – How the RLD Catalog Works
- Reference Standard: A Reference Listed Drug (RLD) is the originator or benchmark product designated by the NMPA against which a generic chemical drug must demonstrate quality and consistency (typically via bioequivalence studies) to support marketing approval in China.
- Generic Approval Pathway: Inclusion in the catalog gives generic sponsors a clear comparator for registration filings, reducing development uncertainty and streamlining the consistency evaluation process required for chemical generics.
- Rolling Updates: The catalog is published in successive batches — the 110th to date — reflecting the NMPA’s ongoing effort to keep the reference list aligned with the evolving generic pipeline and marketed product landscape.
- Batch Composition: This batch pairs 28 newly listed specifications with supplementary information for 27 previously listed specifications, a combination of expansion and maintenance typical of the rolling update mechanism. Specific products, indications, and originators in this batch were not disclosed in the source announcement.
Market Impact & Outlook
- Generics Developers: Each new listing opens a defined development pathway for the corresponding generic specification, giving sponsors a concrete comparator for bioequivalence programs and registration planning.
- Originator Exposure: Products newly designated as RLDs become the benchmark for generic entry, a factor in lifecycle and pricing strategy for originator holders in China.
- Regulatory Cadence: With the catalog now at its 110th batch, the steady publication rhythm signals continued NMPA commitment to the generic consistency evaluation framework as a pillar of China’s pharmaceutical quality upgrade.
Forward‑Looking Statements
This brief describes a regulatory catalog publication. Listing of a drug specification as a Reference Listed Drug does not by itself confer approval on any generic product; subsequent registration applications remain subject to NMPA review. The composition and effect of future batches may vary, and no commercial outcomes should be inferred from this update.-Fineline Info & Tech
