Category Archives: NMPA

China’s CDE Opens Public Consultation on the 110th Batch Catalogue of Reference Preparations for Chemical Generic Drugs – Comment Window Runs 7–18 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

CDE Seeks Input on Multivalent Vaccine Clinical Trial Q&A Guidelines

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Beijing, Sept 4, 2026 — China’s Center for Drug Evaluation (CDE) has released for public comment a draft Q&A document accompanying its Technical Guidelines for Clinical Trials of Multivalent Vaccines, aiming to refine regulatory standards for combination vaccine development by addressing common questions encountered in clinical research, with a comment window of one month from publication.

Consultation Snapshot

Attribute	Detail
Document	Q&A Document of the Technical Guidelines for Clinical Trials of Multivalent Vaccines (Draft for Comments)
Issuing body	Center for Drug Evaluation (CDE), NMPA
Basis	Published Technical Guidelines for Clinical Trials of Multivalent Vaccines
Purpose	Address common issues and further refine regulatory standards for combination vaccine clinical R&D
Comment period	One month from publication (Sept 4, 2026)
Contacts	liuyalin@cde.org.cn; pany@cde.org.cn; suy@cde.org.cn

Regulatory Context

Multivalent vaccines—known in Chinese regulatory parlance as “多联疫苗,” or combination vaccines—deliver antigens against multiple pathogens in a single formulation, exemplified by products such as the pentavalent DTP-IPV-Hib vaccine. Combination vaccines raise distinctive clinical trial questions that single-antigen products do not: immune interference between components, comparability with co-administered or predecessor vaccines, choice of immunobridging strategies, and consistency of batch-to-batch immunogenicity across multiple antigens. The CDE’s underlying guideline established the framework for such trials; the new Q&A document drills into recurring issues sponsors face when designing programs, offering granular interpretation that converts principle-level text into actionable standards for trial design, endpoint selection and submission packages.

Market Impact Analysis

For China’s fast-growing vaccine sector, the Q&A document lowers a key source of development uncertainty. Domestic manufacturers—several of which are pursuing combination vaccines to upgrade beyond single-antigen pediatric products—have faced ambiguity on how much comparability data regulators expect against licensed combination or component vaccines, and on acceptable immunobridging pathways. Clarified answers should compress pre-submission negotiation cycles, reduce the risk of costly trial redesigns, and give sponsors firmer ground for portfolio planning in pediatric and adult combination products.

The timing is notable: China’s vaccine market is undergoing consolidation and technological upgrading following the rollout of the Vaccine Administration Law, and combination vaccines represent one of the clearest premium segments where domestic players still trail imported pentavalent and hexavalent products. By refining guidance now, the CDE is supporting the domestic pipeline’s ability to compete in high-value multivalent formulations—an area with strong public health rationale, since combination vaccines improve immunization coverage and reduce injection burden for infants.

The one-month comment window, standard for CDE guideline consultations, suggests a near-term finalization timeline, with the final Q&A potentially in force before mid-2027.

Forward-Looking Statement

Industry participants are expected to submit feedback to the CDE’s designated contacts before the deadline in early October 2026, with the final Q&A document likely issued after the agency reviews and incorporates comments. Once adopted, the clarified standards should accelerate clinical trial initiation and review for combination vaccine candidates, and market watchers will look for specificity on immune-interference evaluation, comparability requirements against licensed products, and immunobridging acceptance criteria—the provisions most likely to shape development costs and timelines. The document also signals continued build-out of China’s vaccine regulatory toolkit, with future refinements anticipated as domestic multivalent candidates advance into late-stage trials and registration.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/bb2cfb685e7dde58e2dbc39b09f1dd3d

CDE Opens Comment Period on TCM Specification Change Guidelines

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Beijing, Sept 4, 2026 — China’s Center for Drug Evaluation (CDE) has released for public comment a draft technical guideline governing specification changes to already-marketed traditional Chinese medicine (TCM) products, refining requirements set out in the agency’s existing trial guideline on pharmaceutical changes for marketed TCM drugs, with a comment window of one month from publication.

Consultation Snapshot

Attribute	Detail
Document	Technical Guidelines for Research on Changes in Specifications of Listed TCM (Draft for Comments)
Issuing body	Center for Drug Evaluation (CDE), NMPA
Purpose	Detail specification-change requirements under the trial guideline on pharmaceutical changes for marketed TCM
Comment period	One month from publication (Sept 4, 2026)
Contact	Department of TCM and Ethnic Drug Pharmacy Affairs
Email	zyyxzdyz@cde.org.cn (subject line must read “Specification Change”)

Regulatory Context

In China’s post-approval change framework, “specifications” (规格) define a marketed drug’s dosage strength, unit-dose content or package configuration. For traditional Chinese medicines—spanning tablets, capsules, granules and oral liquids—specification changes are frequently needed to match clinical dosing practice, improve pediatric or geriatric usability, or align products with updated manufacturing scales. The draft guideline builds on the Technical Guidelines for Pharmaceutical Change Research of Listed TCM (Trial), which established a risk-based classification for post-approval changes to marketed Chinese patent medicines. The new document isolates specification changes for dedicated treatment, giving manufacturers a clearer evidentiary roadmap—covering pharmaceutical equivalence, quality consistency and, where warranted, clinical bridging studies—for filing such changes with provincial or national regulators.

Market Impact Analysis

The consultation addresses a long-standing friction point for China’s TCM sector: many marketed Chinese patent medicines carry legacy specifications that no longer fit modern clinical demand, yet holders have lacked granular guidance on the research package needed to change them. By detailing the requirements, CDE is effectively lowering the regulatory uncertainty around specification amendments—reducing the risk that holders over-invest in unnecessary bridging studies or under-invest and face rejection.

For TCM manufacturers, the guideline creates a practical pathway to refresh aging product portfolios: adjusting strengths to match evidence-based dosing, consolidating multiple specifications for supply-chain efficiency, or improving patient adherence through better-suited dosage configurations. The CDE frames the initiative explicitly as serving clinical medication needs and supporting the development of the TCM industry, consistent with Beijing’s broader policy push to modernize traditional Chinese medicine under dedicated state support measures.

The one-month comment window—standard for CDE technical guideline consultations—signals an intent to finalize the guideline on a near-term timeline, suggesting specification-change filings under the new framework could begin well before mid-2027.

Forward-Looking Statement

Industry participants are expected to submit feedback to the CDE’s TCM and Ethnic Drug Pharmacy department before the deadline in early October 2026, with the final guideline likely issued after the agency reviews and incorporates comments. Once adopted, the guideline should produce a measurable uptick in specification-change applications for marketed TCM products as holders align legacy specifications with current clinical practice. Market watchers will look for clarity in the final text on risk classification thresholds, the conditions triggering clinical bridging requirements, and consistency-evaluation standards—provisions that will determine how readily smaller TCM manufacturers can utilize the pathway. The draft also points toward continued refinement of China’s post-approval change system for traditional medicines, potentially extending to other change categories in future guideline iterations.-China Health Reform Pulse

Policy Source: https://www.cde.org.cn/main/news/viewInfoCommon/c5da4ee5650bdab08619259372885f93