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2 min read
Introduction
China’s National Medical Products Administration (NMPA) has transitioned to the electronic Common Technical Document (eCTD) format for drug submissions, bringing it in line with global Regulatory standards. However, successful eCTD submissions in China require unique compliance demands, especially in the Module 1 structure, lifecycle management, and platform-specific technical validation.
For Regulatory professionals, understanding these nuances is key to preventing submission rejection and expediting drug approvals. The following best practices will help streamline your approach to the China eCTD landscape and align with the evolving drug approval process in China.
1. Customize Module 1 to Meet NMPA's Regional Specifications
Unlike ICH’s global CTD format, China’s drug Regulatory compliance mandates significant customization in Module 1, major documentation including:
- The application form filled in online
- Cover letter
- Product labelling, SmPC, and artwork aligned with China’s prescribing regulations
- Pharmaceutical development information sheet and pharmaceutical manufacturing information sheet
- Specification & Manufacturing process / Manufacturing and testing procedures
- Master file list of the manufacturing site
- Regional certificates (GMP, GLP, MAH authorization)
This level of customization is vital to ensure alignment with eCTD China guidelines and minimize technical or administrative rejections
2. Use NMPA-Compliant eCTD Software Tools
Not all global publishing tools comply with the China eCTD schema. Use software validated for NMPA XML backbone requirements and compatible with:
- Chinese granularity and node IDs
- Metadata tagging aligned to CDE’s lifecycle conventions
- Regional validation rules
Tools not validated for eCTD submission in China can lead to schema mismatch and submission failures.
3. Conduct Pre-Submission Validation Using CDE’s Native Validator
Technical rejections commonly result from:
- Invalid XML
- Missing lifecycle elements
- Improper PDF formatting
Running submissions through the CDE Validator is crucial for compliance with China’s eCTD requirements and supports first-time-right submission outcomes.4. Standardize Document Format and Structure.
4. Standardize Document Format and Structure
NMPA enforces strict formatting for CTD submissions in China:
- PDFs must be bookmarked, text searchable, and font-embedded
- No JavaScript, hyperlinks outside the submission, or encrypted files
- Use Chinese fonts such as SimSun (宋体) for Simplified Chinese content
Consistent document standards are foundational for a smooth China drug approval process.
5. Register and Submit via the CDE Portal with Digital Signature
eCTD sequences are submitted through the Drug Registration System:
- Register as a sponsor or via a local agent
- Submit digitally signed eCTD packages (in .zip format)
- Use an NMPA-recognized certificate authority (CA)
This is central to both the generic drug approval process in China and innovative submissions.
6. Ensure Accurate Chinese Translation and Localization
Module 1 and clinical summaries (Module 2) must be translated to Simplified Chinese. To align with China's drug Regulatory compliance, consider:
- Avoid machine translation; use certified bilingual Regulatory professionals
- Ensure consistency in terminology with CDE’s controlled vocabulary
- Back-translate to check accuracy against the source clinical data
Terminology should match CDE’s controlled vocabulary, ensuring local alignment during China clinical trial approval processes.
7. Plan for Lifecycle Management from Day One
Create a submission tracker for:
- Initial sequences
- Amendments
- Updates
- Variations and renewals
Follow China-specific sequence numbering (e.g., 0000, 0001, etc.) and document replacement flags.
8. Monitor NMPA/CDE Policy Updates Frequently
China’s Regulatory framework is evolving rapidly. Monitor:
- Center for Drug Evaluation (CDE) News
- Pilot project outcomes
- Updates to validation rules, file formats, and reviewer expectations
Subscribe to alerts or appoint a dedicated compliance contact in your RA team.
Why This Topic Matters for Pharma Companies and Regulatory Professionals
Non-compliant eCTD submissions in China are rejected without technical review, causing months of delay. With China’s growing role as both a manufacturing hub and strategic market, getting eCTD submissions right from the start ensures:
- Faster review timelines
- Reduced risk of rework
- Strategic alignment with global Regulatory planning
How You Can Leverage These Best Practices
- Integrate these best practices into your global eCTD preparation workflow
- Localize early: prepare the Chinese Module 1 in tandem with the core CTD
- Partner with in-country Regulatory experts for compliance on China clinical trial approval processes and China new drug application workflows.
Our Regulatory team specializes in end-to-end China eCTD services—from authoring and validation to lifecycle updates and submission management.
