China’s Center for Drug Evaluation (CDE) has released the draft for comment of the 111st Batch of the Catalogue of Reference Preparations for Chemical Generic Drugs, proposing 25 newly added specifications and setting a public feedback window that closes on 27 October 2026.
Contents
Policy Snapshot
| Item | Detail |
|---|---|
| Agency | Center for Drug Evaluation (CDE), NMPA (China) |
| Document | Draft for comment – 111st Batch, Catalogue of Reference Preparations for Chemical Generic Drugs |
| Release Date | 15 October 2026 |
| Comment Deadline | 27 October 2026 |
| Newly Added Specifications | 25 |
| Supplementary Information | 20 specifications |
| Not Passed Review | 14 specifications |
| Next Steps | Finalization of the catalogue after the public consultation closes |
Draft Composition
- New Additions: 25 specifications are proposed for first‑time inclusion in the catalogue, extending the pool of designated reference products against which chemical generic drugs must demonstrate quality and efficacy consistency.
- Supplementary Information: For 20 specifications, the draft provides supplementary details – enriching existing catalogue entries with additional reference information for generic developers.
- Failed Review: 14 specifications did not pass review in this batch, signaling the CDE’s continued screening rigor over which products qualify as reference preparations.
- Specific Product Names & Dosage Forms: Not disclosed in the announcement.
Background – The Reference Preparations Framework
- The Catalogue of Reference Preparations designates authoritative reference products – typically originator or internationally recognized drugs – that serve as the benchmark for bioequivalence and consistency evaluation of chemical generic drugs in China.
- Inclusion in the catalogue is a prerequisite step for generic manufacturers pursuing consistency evaluation, directly shaping which comparators are acceptable in regulatory submissions.
- The CDE publishes the catalogue in rolling batches, with each batch opened for public comment before finalization, allowing industry stakeholders to challenge or supplement proposed entries.
Market Impact & Outlook
- Generic Development Pipeline: The 25 newly proposed specifications may unlock or redirect consistency evaluation programs for domestic generic manufacturers working on the corresponding products.
- Compliance Burden: The 14 specifications that failed review highlight that not all candidate products will secure reference status, potentially forcing developers to await future batches or seek alternative comparators.
- Stakeholder Action Window: Manufacturers, originators, and industry associations have until 27 October 2026 to submit feedback – a short, 12‑day consultation window typical of CDE batch drafts.
- Final Batch Content: The finalized 111st batch may differ from the draft depending on comments received; the outcome has not yet been determined.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines and the finalization of the 111st Batch Catalogue of Reference Preparations. Actual outcomes may differ based on public feedback, CDE review decisions, and subsequent regulatory actions.-Fineline Info & Tech
