China’s 2025 Drug Registration Inspection Specification: Major Changes to the Regulatory Framework

Effective August 1, 2025, China’s National Institutes for Food and Drug Control (NIFDC) has implemented the Drug Registration Inspection Specification (2025 Revised Edition), replacing the 2020 trial version. This update, approved by the National Medical Products Administration, aligns with the State Council’s directive - General Office of the State Council Document [2024] No. 53 - to deepen regulatory reform and promote high-quality development in the pharmaceutical industry. The revision introduces targeted improvements to streamline inspection procedures, enhance technical standards, and support more efficient drug review and approval.

Lifecycle-Integrated Testing: Pre-Registration Extended to Supplemental Applications

• Pre-registration testing is now permitted for post-approval changes, enabling manufacturers to align testing with lifecycle planning and reduce regulatory lag.
• Manufacturers must assess changes per CDE’s technical guidance and engage regulators early.
• Testing may proceed in parallel with review, supporting faster turnaround for routine variations.
• Test reports are shared with both applicants and CDE, improving transparency and regulatory coordination.

Strategic Impact: Enables synchronized execution of change control and regulatory submission strategies.

Accelerated Timelines and Operational Flexibility

• Standard timelines remain: 60 working days (testing), 90 days (testing + standard verification).
• Expedited timelines apply to priority and rare disease drugs:
  • - Priority: 50 / 80 days
  • - Rare disease: 40 / 70 days

Additional process enhancements:

• Removal of the 30-day sample submission deadline.
• Digital filing with 5-day turnaround and reduced quantity requirements.
• Sponsors may submit corrections or explanatory supplements during testing.

Strategic Impact: Improves regulatory responsiveness and reduces administrative overhead.

Reduced Sample and Data Burden

• Sample volume reduced from 3× to 2×; rare disease drugs from 9× to 2×.
• Retained samples may be reused if quantity and shelf life are sufficient.

Strategic Impact: Reduces cost and complexity, particularly for low-volume or high-value products.

Streamlined Documentation and Testing Scope

• Chemical Drugs: Only Module 3 Quality Control required; microbial control strategy mandatory for non-sterile products.
• Overseas Drugs: Testing task documents no longer required; import permits and commercial or proposed domestic packaging accepted.
• Multi-Specification Drugs: Submit 3 batches of representative specs (max/min) + 1 batch of other specs.

Strategic Impact: Clarifies regulatory expectations and simplifies dossier preparation.

Integrated Evaluation of APIs, Excipients, and Packaging

• Associated reviews involving APIs and finished dosage forms are now handled by the same testing institution.
• Formalized testing procedures for excipients and packaging:
  • - Triggered by CDE based on review needs.
  • - NIFDC oversees innovative materials; provincial labs handle standard ones.
  • - Appendix 1.5 outlines required documentation.

Strategic Impact: Enhances consistency and aligns with Quality by Design (QbD) principles.

Strategic Summary: Efficiency, Predictability, and Quality Alignment

• Efficiency Gains: Compressed timelines, parallel testing, and sample reuse accelerate regulatory execution.
• Reduced Burden: Lower sample and data requirements reduce operational complexity.
• Quality Assurance: Updated standards reinforce QbD principles and improve regulatory clarity.

Further Information

To read the original announcement about the 2025 Revised Edition of the Drug Registration Inspection Specification released by the National Institutes for Food and Drug Control (NIFDC), please click here.

If you are evaluating how these changes may affect your registration or post-approval strategy in China, contact Cisema for tailored regulatory support.

GET IN TOUCH

🌐 Send us your enquiry

📚 Request our whitepapers

📣 Sign up for our newsletter