By Fineline Cube China’s Center for Drug Evaluation (CDE) announced on September 7, 2026 the selection of the 110th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. The draft is open for public feedback until September 18, 2026.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | Center for Drug Evaluation (CDE), China |
| Action | Selection of the 110th batch of reference preparations for GQCE |
| Document Type | Draft opinion (open for public feedback) |
| Release Date | 7 Sep 2026 |
| Feedback Deadline | 18 Sep 2026 |
Batch Composition
| Category | Count |
|---|---|
| New drugs added to the draft | 27 |
| New specifications added | 25 |
| Drugs that failed to pass review | 5 |
What Reference Preparations Mean for GQCE
- Benchmark Requirement: Under China’s generic quality and consistency evaluation (GQCE) framework, domestic generic drugs must demonstrate bioequivalence and quality consistency against officially designated reference preparations — typically originator or internationally recognized products.
- Market Gatekeeping: Passing GQCE against a listed reference preparation is a prerequisite for generic products to compete in volume‑based procurement (VBP) tenders and retain market access in China.
- Batch Cadence: The 110th batch continues CDE’s rolling expansion of the reference preparation catalog, progressively extending GQCE coverage across therapeutic categories and dosage specifications.
Market Impact & Outlook
- Generic Industry Implications: The addition of 27 drugs and 25 specifications expands the universe of products for which Chinese generic manufacturers can now anchor consistency evaluations, enabling new ANDA‑equivalent filings and VBP eligibility.
- Review Rigor: The failure of 5 drugs to pass review signals continued stringency in CDE’s reference preparation selection criteria, emphasizing quality standards over catalog expansion speed.
- Feedback Window: Stakeholders — including domestic generic manufacturers and multinational originators — have until September 18, 2026 to submit comments before the batch is finalized.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding finalization of the 110th batch and subsequent GQCE implementation. Actual outcomes may differ based on public feedback received during the consultation period and final CDE review decisions.-Fineline Info & Tech