CDE参比发布

CDE参比发布 is a public web portal operated by China's Center for Drug evaluation (CDE) under the National Medical Products Administration. It serves as the official channel for publishing the catalog of reference products (参比制剂) used as benchmarks when developing and reviewing generic drugs. The reference list is a foundational document for the Chinese phArmaceutical industry: manufACTurers must match their generic candidates agAInst a designated reference product before submission, so timely access to the published catalog matters for planning and compliance.

What it does

The site presents the reference product catalog in a browsable, list-based fORMat. Each entry typically IDEntifies the product, its dosage form and specification, the marketing authorization holder, and the originator country, along with Information on how the product was designated. The portal is essentially a regulatory reference lookup tool rather than a computational service; its value lies in making an authoritative, regularly updated list available to anyone with a browser.

Key capabilities

• Published catalog of reference drug products for generic development and review.
• Structured entries covering product name, dosage form, specification, and holder information.
• List-based browsing suitable for regulatory affairs and research reference.
• Official source status, reducing reliance on third-party summaries.
• Accessible without registration or payment for General viewing.

Specific fields, update cadence, and any added features may vary between batches and releases, so users should confirm details against the current official list.

Who it is for

The primary audience is pharmaceutical Professionals: regulatory affairs specialists, formulation scientists, quality and compliance teams, and consultants working on generic drug submissions in China. It is also useful for analysts tracking the Chinese generics market and for academic researchers studying regulatory science. Because the interface is in Simplified Chinese and oriented toward regulatory practice, it is less suited to casual visitors or to non-Chinese regulatory contexts.

How to get started

Open the portal in a web browser and browse the reference product list. Locate entries by product name or by scanning the published batches, and note the specification and holder details for the product you are evaluating. Cross-check the listing date and batch to ensure you are working from the current veRSIon of the catalog before using it in any submission documentation.

Pricing and access caveat

Public viewing of the reference catalog APPears to be free and open, with no subscription indicated. However, access stability from outside mainland China may vary, and the site may be slow or interMITtently unavailable internationally. No AI processing is advertised, and the product should be treated as a regulatory data resource rather than an AI tool; check the official CDE site for authoritative and current information.