CDE Announces Further Proposals to Optimize Innovative Drug Trials in China

China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced a coordinated set of draft policies and technical documents aimed at optimizing the clinical trial approval process for innovative drugs. The reforms, announced on June 16 and 19, 2025, propose a 30-working-day fast-track review mechanism for eligible drugs—down from the current 60-day timeline—and introduce modular submission requirements, strengthened pharmacovigilance systems, and mandatory pre-submission ethics reviews. These initiatives are grounded in the State Council’s regulatory modernization directive (Guo Ban Fa [2024] No. 53) and reflect NMPA’s 2024 pilot experience. Stakeholders are encouraged to review the framework, which is designed to reduce development timelines, enhance global trial integration, and increase compliance clarity across China’s pharmaceutical innovation ecosystem.

🗓️ Public comment deadlines: Submit feedback on the June 16 policy by July 16, 2025, and on the June 19 technical documents by July 18, 2025.

Background and Policy Foundations

The reform package builds upon the “Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry” (Guo Ban Fa [2024] No. 53), as well as pilot work completed by the NMPA in 2024. These efforts aim to enhance China's global competitiveness in drug innovation by removing submission bottlenecks and harmonizing regulatory expectations with international best practices.

Core Policy Changes

• 30-Day Fast-Track Review Mechanism: Reduces the review and approval time for eligible clinical trial applications (INDs) from 60 working days to 30. If technical reviews are delayed, the application automatically transitions to the 60-day implied approval process.

• Eligibility Criteria: Applies to Class 1 innovative drugs (Traditional Chinese Medicine, chemical drugs, biological products) that meet at least one of the following:
  1. Key national support varieties with significant clinical value
  2. Pediatric (SPARK Program) or rare disease drugs (Care Program)
  3. Drugs developed via globally synchronized R&D or MRCTs led by Chinese investigators

• Pre-Submission Requirements: Sponsors must:
  1. Obtain ethics approval from lead clinical institutions
  2. Assess and document investigator capabilities
  3. Initiate ethics and project reviews before submission
  4. Commit to enrolling the first subject within 12 weeks post-approval

Technical Framework and Submission Requirements

• Modular Submission System: New IND applications are divided into Modules 1–5. Module 1 must include a risk control chapter addressing protocol risks and ethics approvals. Modules 2–5 feature tailored standards for drug classes (e.g., virus clearance data for biologics, pharmacology consistency for chemicals).

• Mandatory Ethics and Institutional Contracts: Applicants must submit documentation such as:
  1. Principal site ethics committee approval
  2. Institutional cooperation memoranda
  3. Confirmation of PI qualifications

• Pharmacovigilance (PV) System Enforcement:
  1. dRMPs must be jointly signed by sponsor, PI, and ethics committee
  2. Internal PV departments are required (full outsourcing not allowed)
  3. Documentation includes SOPs, informed consent risk chapters, and IB safety updates

Review Contingency and Fallback Pathways

To accommodate technical review delays (e.g., expert meetings), the system includes a fallback mechanism: applications that exceed 30 days automatically enter the 60-day implied approval track. Applicants will be notified of the transition in writing, ensuring process continuity while maintaining flexibility for complex trial designs.

Tripartite Governance Framework

• Tripartite Risk Management: The “Assessment Report” process introduces shared accountability:
  1. Applicant: Submits a signed commitment letter and conducts internal feasibility review
  2. Principal Investigator: Evaluates protocol practicality and risk mitigation
  3. Ethics Committee: Issues a feasibility opinion (including modifications if needed)

Industry Impact and Strategic Outlook

• Shortened Development Timelines: Eligible global trials may see launch times reduced from 6–9 months to 3–4 months, offering cost savings and faster patient access.

• Regulatory Differentiation: Companies with strong internal compliance systems will benefit most. SMEs dependent on CROs may face new compliance challenges.

• Global Harmonization: Adoption of CTD format and ICH-aligned standards improves China’s position in global regulatory networks and data-sharing ecosystems.

Stakeholders are advised to thoroughly assess the implications of these proposed reforms. Companies may wish to consult regulatory partners like Cisema for technical guidance and support in submitting public comments by the stated deadlines.

Further Information

To read the original announcements, please refer to the June 16, 2025 draft policy on optimizing the review and approval mechanism for innovative drug clinical trials released by the NMPA, and the June 19, 2025 supporting technical documents for clinical trial submissions released by the CDE.

If you are a pharmaceutical company with questions about how the new fast-track clinical trial policies may affect your product development or registration timelines in China, please contact Cisema.

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