CDE Proposes Revised Standards for Written Supplementary Information Requests

On July 24, 2026, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration published the draft “Standards for Issuing Written Supplementary Information Requests during Drug Review” for public comment, with feedback due by August 23, 2026.

The draft identifies circumstances in which CDE may issue a written supplementary information request and distinguishes these from major deficiencies that may support a non-approval conclusion based on the submitted dossier.

For pharmaceutical companies, the draft reinforces the importance of identifying substantive deficiencies before submission and ensuring that the initial dossier provides an adequate basis for technical review.

Why the CDE Is Revising the Standard

The current framework dates to November 2020, when the CDE issued the “Drug Evaluation Center Supplementary Information Work Procedures (Trial)” and its accompanying standard for written requests for additional materials.

Since then, the CDE has released updated technical criteria for identifying major deficiencies in chemical generic drug pharmaceutical research and bioequivalence studies. The revision aligns the supplementary information standard with these newer technical requirements and removes the "Trial" designation from the existing standard.

How the Proposed Standard Would Change the 2020 Framework

A key feature of the proposed revision is a clearer distinction between issues that may be addressed through supplementary information and major deficiencies for which supplementation is not considered appropriate.

The 2020 standard includes circumstances such as substantial revisions to key product documents and issues requiring improvement of risk-control plans but does not consistently distinguish between major and minor deficiencies across all categories.

Issues That May Be Addressed Through Supplementary Information

The proposed standard focuses supplementary information requests on issues that can reasonably be addressed during review, including:

• Minor issues in study design, trial conduct or data analysis
• Differences from current scientific understanding that require explanation
• Minor issues involving active pharmaceutical ingredients, excipients or packaging materials

Major Deficiencies That May Lead to a Non-Approval Conclusion

Where major deficiencies are identified that approach appropriately be addressed through supplementary information, CDE may reach a non-approval conclusion based on the submitted dossier rather than issuing a written supplementary information request.

This makes the distinction between correctable issues and a major deficiency particularly relevant during dossier preparation.

14 Scenarios Where Supplementary Information May Be Requested

The draft lists 14 situations in which the CDE could request additional materials. These fall into five broad categories:

Category 1: Documentation and Scientific Clarification

Unclear documents, minor issues in study design, trial conduct or data analysis, and approaches that differ from current scientific understanding and require explanation.

Category 2: Key Documents and Supporting Analyses

Revisions to quality standards, product information, manufacturing or testing procedures, and further analysis of important safety or efficacy results.

Category 3: Regulatory, Risk and Product Rationale

New requirements arising during review, risk control plans requiring improvement, and insufficient supporting evidence for the proposed product or its intended clinical use.

Category 4: Testing, Inspections and Associated Materials

Minor issues involving active pharmaceutical ingredients, excipients or packaging materials, as well as matters identified through registration testing, inspections or associated review of drug-device combination products.

Category 5: Other Review Matters

Issues arising from substantiated reports, additional stability data needed to support shelf life, and other cases considered by the relevant departmental technical committee.

What Applicants Should Do Now

To prepare for this stricter review environment, companies with active or upcoming China submissions should take the following steps:

• Review Upcoming Submissions: Assess planned China dossiers against the draft standards and identify potential deficiencies before filing.
• Identify High-Risk Gaps: Assess whether potential deficiencies could be considered major and therefore unsuitable for resolution through supplementary information.
• For Chemical Generics, Check Existing Deficiency Standards: Review applicable CMC and bioequivalence material against CDE’s existing technical standards for identifying major deficiencies

Final Thoughts

If finalized, the revised standard would provide applicants with a greater clarity on which issues may be addressed through written supplementary information, and which major deficiencies may instead support a non-approval conclusion. This reinforces the importance of identifying significant scientific and technical gaps before submission.

For assistance assessing how the proposed standard may affect your China submissions or regulatory strategy, contact Cisema.

Further Information

• Explore Cisema’s services for pharmaceutical development and regulatory strategy.
• Learn about Cisema’s pharmaceutical regulatory affairs consulting services.

References

• CDE Notification on Public Comments on the Draft “Standards for Issuing Written Supplementary Information Requests during Drug Review”