Beijing, China – 07 Sep 2026 – The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has published the Catalogue of Reference Preparations for Chemical Generic Drugs (110th Batch) (Draft for Comments) for public consultation, inviting industry feedback through the “Query on Reference Preparation Varieties” module of the official selection application platform until 18 Sep 2026.
Regulatory Milestone
| Item | Detail |
|---|---|
| Issuing Authority | Center for Drug Evaluation (CDE), NMPA |
| Document | Catalogue of Reference Preparations for Chemical Generic Drugs — 110th Batch (Draft for Comments) |
| Policy Basis | NMPA Announcement No. 25 of 2019 — Procedures for the Selection and Determination of Reference Preparations for Chemical Generic Drugs |
| Publication Date | 7 Sep 2026 |
| Comment Period | 7 Sep – 18 Sep 2026 (10 business days) |
| Varieties Covered | See official attachment; count not restated in the notice body |
| Feedback Channel | “Reference Preparation Query Application” module, Reference Preparation Selection Application Platform |
Consultation & Feedback Procedure
- Submission Route: Comments must be filed via the dedicated “query on reference preparation varieties” module on the CDE’s selection application platform — not by mail or email.
- Evidence Standard: To better serve applicants, the CDE requires feedback to be accompanied by sufficient basis and supporting argumentation materials.
- Formalities: Submissions must bear the official seal of the organization, together with the submitter’s real name and contact details — anonymous or unsubstantiated comments will not meet the stated requirements.
Reference Preparation Framework
- Role of Reference Preparations: Designated reference preparations (参比制剂) — typically originator or internationally recognized benchmark products — serve as the comparator standard for bioequivalence studies and quality/therapeutic consistency evaluation of chemical generics in China.
- Batch Mechanism: The CDE publishes the catalogue in sequential batches under the 2019 selection procedure; each finalized batch gives generic developers a definitive comparator for their generic (ANDA‑equivalent) filings.
- Draft‑Stage Leverage: The 10‑business‑day comment window is the industry’s formal opportunity to challenge or refine proposed selections — a step that can materially affect development strategy and clinical study design for generics in the covered varieties.
Market Impact & Outlook
- Pipeline Planning Signal: Generic manufacturers targeting the varieties in the 110th batch should review the draft attachment immediately and calendar the 18 Sep deadline — comparator designation locks in bioequivalence study design and reference‑product sourcing.
- Consistency Evaluation Momentum: The steady cadence of batch releases (now at 110) underscores the NMPA’s continuing push to align China’s generic fleet with international reference standards, a core plank of procurement eligibility and hospital access.
- Compliance Posture: The CDE’s insistence on sealed, evidenced, named submissions indicates that only well‑documented objections are likely to influence the final catalogue — favoring applicants with regulatory‑affairs depth.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the consultation outcome, final composition of the 110th batch catalogue, and subsequent generic development implications. Actual results may differ due to risks including feedback evaluation, revisions between draft and final versions, and future CDE policy announcements.-China Health Reform Pulse
Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/b5a3b0d7d48c754d41577d2536109f0f