How Will NMPA’s 2025 eCTD Update Impact Your Product Launch Timeline?

Beijing, January 23, 2025 — The National Medical Products Administration (NMPA) has officially announced the expanded implementation of the Electronic Common Technical Document (eCTD) for drug submissions in China. Issued under Announcement No. 10, 2025 and effective January 27, 2025, this policy marks a significant milestone in China’s shift toward fully digital Regulatory operations.

This development builds upon the foundation of NMPA Announcement No. 119, 2021 and reinforces China’s broader strategy to embed “Internet + Drug Regulation” into its drug regulatory framework.

Scope of the Expanded eCTD Requirements

The mandate extends the use of eCTD-format submissions to a wider range of drug categories, including both chemical and biological products:

Chemical Drugs

• Clinical Trial Applications (CTAs): Class 1–5 chemical drugs

• Marketing Authorization Applications (MAAs): Class 2, 3, 4, and 5.2 chemical drugs

Biological Products

• CTAs: Class 1–3 preventive biological products, Class 1–3 therapeutic biological products

• MAAs: Class 2 and 3 biological products

From early 2025 onward, all new clinical trial and marketing applications for these categories must be submitted in eCTD format, in accordance with the updated NMPA guidelines.

Key Submission Expectations for Applicants

To comply with the new framework, pharmaceutical companies must:

• Prepare eCTD-compliant electronic dossiers based on the latest NMPA/CDE technical standards

• Use the online transmission platform for dossier submissions wherever possible

Detailed instructions are outlined in the “Notice on Pilot Implementation of Online Transmission for Drug Registration Electronic Application Dossier Submission” available on the CDE website.

Why This Matters for Industry

The expansion of eCTD goes far beyond a technical requirement. For drug developers, it enables:

• Faster application reviews and streamlined approvals

• Standardized dossier structures, improving submission quality

• Stronger collaboration between industry and regulators

• Enhanced lifecycle management, improving data tracking and version control

The alignment with ICH M4 standards also allows multinational sponsors to better synchronize filings across China and other global regulatory agencies.

A Step Toward Full Digitalization

This initiative reflects China’s long-term vision of a digitally integrated Regulatory ecosystem, with benefits including:

• Greater efficiency and transparency in the review process

• Seamless integration of post-marketing, safety, and change control data

• A foundation for future AI-driven Regulatory tools and automation

As a result, paper-based or manual submission methods will soon become obsolete in China’s regulatory environment.

Global Regulatory Solutions and Services Company