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2 min read
Beijing, January 23, 2025 — In a decisive move to advance digital Regulatory practices, the National Medical Products Administration (NMPA) has announced the expansion of the Electronic Common Technical Document (eCTD) implementation for medicinal product submissions in China. Effective January 27, 2025, this update—issued under Announcement No.10, 2025—represents a major step toward streamlining the drug registration lifecycle and modernizing the Regulatory environment for pharmaceuticals.
This expansion builds on the groundwork laid by NMPA Announcement No.119, 2021, and aligns with the country’s strategic initiative to integrate “Internet + Drug Regulation” into its Regulatory infrastructure.
What Does the Expansion Cover?
The updated scope mandates that eCTD-format submissions be adopted for the following medicinal product categories:
Chemical Drugs
- Clinical Trial Applications for:
- Class 1 to 5 chemical drugs
- Marketing Authorization Applications (MAA) for:
- Class 2, 3, 4, and 5.2 chemical drugs
Biological Products
- Clinical Trial Applications for:
- Class 1 to 3 preventive biological products
- Class 1 to 3 therapeutic biological products
- Marketing Authorization Applications for:
- Class 2 and 3 biological products
This means that from early 2025, all pharmaceutical companies submitting new clinical or marketing applications for a broad range of medicinal products—both chemical and biologic—must adopt the eCTD format as per China’s latest Regulatory requirements.
Submission Requirements for Pharmaceutical Companies
To ensure compliance, applicants must:
- Prepare and submit eCTD-compliant electronic dossiers that meet the latest NMPA/CDE technical specifications
- Preferably use online transmission systems for electronic submission
The “Notice on Pilot Implementation of Online Transmission for Drug Registration Electronic Application Dossier Submission”, available on the CDE website, provides detailed guidance.
Why This Matters for Drug Developers
The eCTD expansion represents more than a formatting change—it’s a significant enabler for:
- Accelerated application processing and review timelines
- Greater consistency and standardization across Regulatory dossiers
- Enhanced collaboration and communication with Regulatory authorities
- Improved traceability and lifecycle management for medicinal product data
The shift aligns China’s Regulatory processes with ICH M4 standards, making it easier for global companies to plan simultaneous or sequential filings in China alongside other regulated markets.
Toward a Fully Digital Regulatory Framework
China's commitment to expanding eCTD reflects a broader goal: building a digitally integrated Regulatory ecosystem. This initiative supports:
- Efficiency and transparency in the drug approval process
- Integration of pharmacovigilance, change control, and post-marketing data
- Readiness for future AI-enabled Regulatory tools and automation
For medicinal product sponsors, this signals a new baseline: manual or paper-based dossiers will soon be outdated.
Final Thoughts
The NMPA’s expanded eCTD mandate is a critical milestone in China’s journey toward global Regulatory harmonization. For pharmaceutical companies seeking to submit clinical trial or marketing authorization applications for medicinal products, eCTD is now the standard submission format, not a future consideration.
With the scope now including preventive and therapeutic biologics and non-innovator chemical drugs, companies must act swiftly to align their documentation systems, workflows, and publishing tools.
Need support with eCTD dossier preparation or submission in China?
Freyr’s global Regulatory experts help life sciences companies navigate NMPA’s eCTD compliance requirements—from dossier authoring and publishing to lifecycle management and online transmission.
Contact us to simplify your next medicinal product submission to the Chinese market.
