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2 min read
In the competitive landscape of China’s pharmaceutical market, dossier accuracy determines how fast a product enters the market. The National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE) have become more stringent with eCTD validation, data integrity, and Regulatory documentation standards.
For companies pursuing drug registration in China, a comprehensive Dossier Quality Control (QC) checklist is vital. A single formatting error or data mismatch in the CTD/eCTD submission can delay approvals or trigger technical rejections.
This guide provides a module-by-module eCTD QC checklist, built for China NMPA dossier submission and aligned with ICH CTD and CDE eCTD technical validation requirements.
1. General QC — Before Submission
Goal: Validate completeness and compliance before initiating the China drug registration process.
Checklist:
- Confirm product classification (imported drug / domestic / biologic / TCM).
- Use the latest NMPA eCTD template and CDE guidance.
- Verify all documents are in Simplified Chinese.
- Ensure consistent applicant and Marketing Authorization Holder (MAH) details.
- Authenticate GMP, CPP, and/or FSC certificates.
- Maintain PDF/A compliance, metadata accuracy, and file naming integrity.
- Conduct a dossier validation pre-check.
2. Module 1 — Administrative & Product Information
Goal: Align administrative data with NMPA medicinal product registration requirements.
Checklist:
- Updated application form and PoA.
- Cover letter in Chinese.
- Local agent authorization validated.
- Labels and package inserts match NMPA labeling rules.
- Information required for inspection
- INN name verification
- Pharmacovigilance and/or RMP
- Translation accuracy cross-checked by QA.
3. Module 3 — Quality (CMC)
Goal: Ensure CMC compliance for China drug submissions and data reproducibility.
Follow ICH Module 4 Checklist with special considerations as below:
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- Analytical procedures and Specifications align with Chinese Pharmacopoeia.
- CoA and analytical method documentation complete.
4. Module 4 — Non-clinical Studies
Goal: Confirm non-clinical data meets GLP and NMPA requirements.
Follow ICH Module 5 Checklist with considerations as below:
- GLP statements and QA certification included.
- Toxicity and safety studies summarized.
- English-Chinese translation checked.
5. Module 5 — Clinical Studies
Goal: Verify clinical data quality for CDE clinical dossier review.
Follow ICH Module 5 Checklist with considerations as below:
- Chinese patient data or bridging study justification.
- Consistency with global clinical summaries.
- AE tables and datasets validated.
- GCP compliance statement verified.
- Clinical trial database
6. eCTD Technical Validation
Goal: Ensure the CDE eCTD validation passes without errors.
Checklist:
- Folder structure per CDE eCTD specifications.
- XML backbone validated.
- Hyperlinks active and metadata complete.
- Validation report archived.
- Virus self-check
7. Post-QC & Submission Readiness
Goal: Achieve final submission readiness for China NMPA drug registration.
Checklist:
- QA sign-off completed.
- Cross-module consistency confirmed.
- Version control implemented.
- Submission checksum validated.
Why Dossier QC Matters
As China transitions fully to ICH-aligned CTD and eCTD formats, dossier quality now directly influences Regulatory review timelines, credibility, and approval outcomes.
A consistent, validated QC process helps avoid:
- Technical rejection by CDE
- Data inconsistency queries
- Faster first-cycle approval
Preparing a CTD/eCTD dossier for NMPA submission?
Let Freyr’s Regulatory Affairs experts in China help you ensure accuracy, compliance, and faster market entry.
