Tag Archives: GQCE

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

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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

ItemDetail
Issuing AuthorityCenter for Drug Evaluation (CDE), NMPA
DocumentCatalogue of Reference Preparations for Chemical Generic Drugs — 110th Batch (Draft for Comments)
Policy BasisNMPA Announcement No. 25 of 2019 — Procedures for the Selection and Determination of Reference Preparations for Chemical Generic Drugs
Publication Date7 Sep 2026
Comment Period7 Sep – 18 Sep 2026 (10 business days)
Varieties CoveredSee 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

Hunan Province Announces Complaint Handling for May 2025 Drug Listing Applications

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Hunan Province’s Medical Security Administration has released a notice detailing the handling of complaints regarding the drug listing applications for new drugs, reference formulations, and approved drugs in May 2025. The announcement, published on May 27, 2025, reflects the province’s commitment to transparency and accountability in its pharmaceutical procurement process.

During the public display period of the application results, a total of five complaints were received. The handling opinions have been integrated into Hunan’s Medical Security Information Platform’s tender and procurement management system. Companies involved are required to check the complaint module for specific outcomes.

For products with reconfirmed price limits, companies must confirm the prices in the price linkage management module by 5:00 PM on May 30, 2025. Failure to do so will result in the products being included in the next round of reapplication. This strict timeline underscores the importance of prompt action by pharmaceutical companies to ensure compliance and avoid delays in market access.

Strategic Implications for Pharmaceutical Companies

The notice serves as a clear directive for pharmaceutical companies operating in Hunan Province. It highlights the need for vigilance during the application and public display periods, as well as the importance of timely response to any complaints or adjustments required by the regulatory authority.

For companies with products undergoing price reconfirmation, the deadline is a critical factor. Missing the deadline could lead to significant delays, potentially affecting market entry and revenue generation. Therefore, companies must prioritize efficient communication channels and ensure that their internal processes are aligned with the regulatory requirements.

Broader Context and Future Outlook

This policy reflects a broader trend in China’s pharmaceutical sector, where regulatory authorities are increasingly focusing on transparency and accountability in drug procurement. Hunan Province’s initiative is part of a nationwide effort to streamline the drug listing process and enhance the efficiency of the healthcare supply chain.

Looking ahead, pharmaceutical companies should expect continued scrutiny of their applications and a need for robust compliance mechanisms. The use of digital platforms for complaint handling and price confirmation also highlights the importance of technological proficiency in navigating the regulatory environment.-China Health Reform Pulse

Policy Source: http://ybj.hunan.gov.cn/ybj/first113541/firstF/f3113607/202505/t20250527_33684054.html