CDE Releases Draft Measures to Enhance Drug R&D and Review Communication

On 19 September 2025, China’s Center for Drug Evaluation (CDE) released the “Administrative Measures for Communication and Exchange on Drug R&D and Technical Review (2025 Draft for Comments),” a major update to the 2020 version. Public consultation will remain open until 19 October 2025.

The proposed changes include:

Defining communication formats.
Expanding mandatory interaction points.
Introducing applicant self-assessment mechanism for communication.
Establishes priority labelling for certain products.
Allowing rolling submissions of materials.
Assigning “communication exchange product codes” to archive communications relating to a drug.

These measures aim to clarify regulatory expectations and improve the consistency of technical reviews for pharmaceutical companies in China.

Key Takeaways

The CDE’s 2025 draft introduces six major updates to China’s drug R&D communication framework, emphasising applicant-initiated interactions and lifecycle traceability.
Mandatory regulatory checkpoints now include pre-Phase III and traditional medicine applications, increasing predictability for global development programs.
Lifecycle-based communication codes will enhance regulatory transparency and consistency across product portfolios.
Public consultation is open until 19 October 2025; timely stakeholder engagement is recommended.

Background on the CDE 2025 Draft Regulatory Communication Measures

The 2020 framework listed communication methods without specifying timing or responsibilities. The 2025 draft replaces this with a structured system that defines how and when companies should communicate with regulators and links exchanges across the product lifecycle.

This structured approach supports China’s goal of improving transparency, predictability, and regulatory alignment with development timelines.

Key Regulatory Changes

The draft introduces six key changes that reshape how companies interact with the CDE throughout development and review.

1. Clearer Definition of Drug R&D Communication in China

The draft defines communication as an applicant-initiated process based on R&D needs. Two formats are introduced:

Written responses for structured technical exchanges that do not require meetings
Formal meetings for direct discussions between applicants and reviewers

This replaces the broader 2020 framework, which referred to communication methods such as in-person meetings, video calls, telephone calls, or written exchanges without emphasising applicant-led initiation.

2. Expanded Mandatory Communication Requirements for Pharmaceutical Companies

Building on this clearer definition, the draft expands the scope of mandatory communication. In addition to existing requirements for conditional approvals, priority review procedures, and pre-clinical or pre-market stages for new drugs and biologics, companies must now communicate with regulators:

Before initiating Phase III clinical trials
Prior to pre-market applications for classical Chinese compound preparations and same-name, same-formula traditional Chinese medicines

These additional checkpoints are designed to ensure alignment at critical stages of product development.

3. New Self-Assessment Mechanism for Applicants

Applicants must evaluate both the necessity and readiness of communication requests before submission. This step is designed to ensure that discussions with regulators are targeted and technically robust, limiting inefficient or premature interactions.

4. Priority Labelling to Accelerate High-Value Drug Development

Products that address significant clinical needs may receive priority labelling, including:

Innovative drugs
Orphan drugs
Other products with high clinical value

This designation enables the CDE to allocate review resources more efficiently and provide faster feedback for high-impact products.

5. More Flexible Submission and Review Procedures

The draft allows applicants to:

Submit supporting materials in stages rather than as a single package
Request a consolidated set of follow-up questions after written exchanges

These options streamline communication and help maintain clear timelines during review.

6. Lifecycle-Based Communication Codes

Each product will receive a unique communication exchange code linking all regulatory interactions from development through post-marketing. This improves traceability across review teams, strengthens consistency across stages, and provides companies with a structured regulatory record throughout the lifecycle.

Implementation Timeline

The draft measures are open for public consultation until 18 October 2025. Although the notice does not specify when the final version will be issued, it is expected to be released in October 2026 following the review of stakeholder feedback, finalisation of the document, and completion of internal process reviews. Implementation will then proceed in phases to allow companies adequate time to adapt their internal systems.

Next Steps for Pharmaceutical Companies

Pharmaceutical companies developing drugs for the Chinese market will need to adapt internal processes to align with the new regulatory communication framework.

Key adjustments include:

Integrating new CDE communication milestones into global development timelines to avoid delays at critical China-specific checkpoints.
Proactively assess portfolio products for eligibility under the new priority labelling scheme (e.g., innovative or orphan drugs). Update internal SOPs and regulatory information systems to accommodate lifecycle communication codes and rolling submissions.
Engage with local affiliates and legal agents to ensure readiness for the expanded mandatory communication requirements.

Taking early steps in these areas may support smoother adaptation once the final measures are implemented.

The Bottom Line: A More Predictable Regulatory Pathway in China

The 2025 draft introduces a clear and coordinated communication framework. By formalising communication methods, setting mandatory interaction points, and applying lifecycle codes, the CDE aims to improve regulatory oversight and provide companies with greater predictability.

Pharmaceutical companies with active or planned development projects in China should review the draft, assess its impact on development timelines, and adjust internal procedures accordingly.

Cisema encourages stakeholders to participate in the consultation process and assess how the proposed measures may affect their current and upcoming product submissions. With more than 20 years of experience supporting life sciences companies in China, Cisema can provide strategic guidance and practical support through these regulatory changes.

Get in touch with Cisema today to discuss what these draft guidelines mean for your products.