China’s Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA), released the draft for comment of the 112th Batch of the Catalogue of Reference Preparations for Chemical Generic Drugs, with public feedback accepted until 20 November 2026 — the latest iteration of the reference standard framework that anchors China’s generic drug quality and consistency evaluation regime.
Regulatory Snapshot
| Item | Detail |
|---|---|
| Agency | Center for Drug Evaluation (CDE), NMPA (China) |
| Document | Draft for comment — 112th Batch of Catalogue of Reference Preparations for Chemical Generic Drugs |
| Release Date | 9 November 2026 |
| Comment Deadline | 20 November 2026 |
| Status | Draft; subject to public feedback before finalization |
Draft Composition
| Category | Specifications |
|---|---|
| Newly added specifications | 7 |
| Supplementary information for existing specifications | 35 |
| Specifications that have not passed review | 16 |
Policy Background – The Reference Preparations Framework
- Purpose: The Catalogue of Reference Preparations designates the originator or internationally recognized reference products against which domestic chemical generic drugs must demonstrate quality and therapeutic consistency — the foundational requirement for generic approval in China.
- Mechanism: Generic applicants conduct consistency evaluations comparing their products to the CDE‑listed reference preparation; inclusion in a catalogue batch provides the regulatory anchor for development, bioequivalence strategy, and registration dossiers.
- Batch Cadence: The CDE publishes the catalogue in sequential batches — this being the 112th — reflecting the regulator’s rolling, systematic expansion of reference standards across the chemical drug landscape.
- Comment Process: The draft‑for‑comment stage allows industry stakeholders to submit feedback on proposed specifications before the CDE finalizes the batch, consistent with its transparent rulemaking practice.
Market Impact & Outlook
- Generic Development Clarity: Once finalized, the batch gives Chinese generic manufacturers confirmed reference standards for the covered specifications, enabling alignment of formulation and bioequivalence programs and reducing development uncertainty.
- Quality Bar Reinforcement: The designation of 16 specifications that have not passed review underscores the CDE’s quality‑first screening — products failing to meet reference criteria are excluded, raising the evidentiary standard across the catalogue.
- Industry Action Window: Stakeholders have until 20 November 2026 to shape the final batch, a short comment window that makes prompt review of the added and supplementary specifications essential for affected sponsors and generic filers.
- Competitive Dynamics: Reference preparation listings typically precede generic entry waves in the covered therapeutic areas, with first‑to‑file generics benchmarked to the listed standards gaining timing advantage in China’s volume‑based procurement environment.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the finalization of the 112th Batch of the Catalogue of Reference Preparations, the outcome of the public comment process, and subsequent implications for generic drug development and approval in China. Actual results may differ due to risks including revisions arising from public feedback, regulatory timing, and changes in consistency evaluation requirements.-Fineline Info & Tech
