In recent years, China's pharmaceutical innovation vitality has continued to surge. According to data from Pharma Intelligence, the number of drug registration applications accepted by the CDE reached 18,466 in 2025, a year-on-year increase of 7.27%, marking the highest level in recent years. This surge in application volume not only reflects the industry's heightened enthusiasm for research and development but also highlights the shortcomings of the traditional application model, such as chaotic document management and low review efficiency. Against this backdrop, the eCTD reform has become a key driver for breaking through these challenges, propelling China's drug registration process toward a new era characterized by greater precision and standardization.

Looking back at the progress of electronic drug submission in China, regulatory authorities have consistently adhered to a strategy of "small steps, rapid advancement, and steady iteration," implementing various reform measures in an orderly manner: In March 2019, the draft standard eCTD 3.2 was released, marking the beginning of eCTD compliance in China; in December 2021, trial submissions of eCTD were officially launched, ushering China's drug registration into a new digital phase; in January 2025, the scope of eCTD implementation was expanded further; in March 2026, the eCTD 3.2 standard was upgraded with another expansion of its application scope, accompanied by simultaneous updates to technical validation and supporting software; on May 27,2026, the eCTD v4.0 guidance principles (public consultation draft) were released, signaling a milestone upgrade in the format for drug registration submissions.

The public consultation on the eCTD v4.0 guidelines marks the most significant version upgrade in China's eCTD reform since its inception.

Compared to eCTD 3.2, version 4.0 represents a "major structural revolution at the foundational level." The changes are primarily reflected in three aspects: alterations to sequence numbers—replacing the traditional four-digit codes (e.g., 0000,0001) with integers starting from 1.

Streamlining the XML framework: The two widely adopted skeletal structures—regionally-specific regional.xml and index-specific index.xml—were merged in version 4.0 into a unified submissionunit.xml file.

The evolution of file organization: Files have evolved from traditional leaf nodes to a more flexible, metadata-capable COU structure.

The new submission requirements impose higher demands on the professional competence and adaptability of registrants, and eCTD submissions must be completed using specialized software tools, presenting a significant new challenge for domestic pharmaceutical registration practitioners.

To address the practical challenges of eCTD submission, the eCTD system was developed, offering four core advantages to support registrants throughout their application process: Stability and Compliance – fully compliant with eCTD regulations and standard guidelines in major global regions such as China, the United States, and the European Union, passing regulatory validation and review; Supported by seasoned pharmaceutical registration experts providing comprehensive eCTD submission assistance and full-process registration services.

Technology Leadership: Self-developed architecture using a B/S model, supporting flexible deployment in both cloud and on-premises environments; no dedicated software required—log in via browser for immediate use, with one-time deployment applicable across the entire organization for seamless collaboration; integrated with registered file cloud storage to simplify complex file management, ensuring efficiency and convenience.

Comprehensive functionality: includes automatic file format validation and repair, online attribute verification, eCTD assembly and publication, hyperlink and bookmark creation, eCTD lifecycle management, eCTD file management, user permission management, and multi-user collaboration modules.

Seamless transition: Compliant with the underlying upgrade logic of eCTD 4.0, fully compatible with version 3.2; the front-end interface remains highly consistent with previous versions, while the core document framework from Module 1 to Module 5 stays unchanged—regulatory officers need not readapt to the infrastructure, as the underlying XML logic is automatically optimized by the system.

The digitalization and internationalization of China's drug registration are advancing relentlessly, and the advent of eCTD 4.0 is an inevitable trend. The process of digitalizing and internationalizing China's drug registration continues to accelerate, making the implementation of eCTD 4.0 a necessary direction for industry development. Instead of worrying about technological changes, it is better to actively experiment with and familiarize oneself with eCTD 3.2 submissions in daily work. With a solid foundation, RA can achieve success regardless of version evolution. Selecting the appropriate eCTD system provides a robust technical guarantee for this confidence.

Seize the reform opportunities amid the launch of eCTD Version 4.0 electronic submission for pharmaceuticals across ChinaPartner with Dingkang for regulatory affairs and sail smoothly through the new regulatory upgrade

China’s pharmaceutical electronic submission has officially upgraded to eCTD V4.0. The regulatory framework has shifted from hybrid paper-based and fragmented electronic filing to an internationally aligned metadata-driven submission system, with fully restructured file architecture, validation criteria and cross-border recognition rules. Most pharmaceutical enterprises are confronted with challenges including dossier restructuring, system adaptation and repeated submission revisions.

Dingkang Pharmaceutical boasts a professional Regulatory Affairs Department, whose core team members possess years of hands-on experience in drug regulatory registration and comply with ICH international standards. Our team has mastered practical operations for eCTD V4.0 well ahead of the official rollout:

✅ Proficient in compiling dossiers per eCTD V4.0 requirements for APIs and finished dosage forms for clinical trial and marketing applications in China; capable of overcoming technical hurdles including standalone XML file construction and UUID coding & archiving of all submission documents.

✅ One-stop dual-registration service available: domestic NMPA eCTD V4.0 filing plus updated electronic submissions for FDA and EMA markets, enabling cross-region dossier reuse to cut R&D and registration costs significantly.

✅ Special transitional service for existing marketed products: batch conversion of legacy dossiers from v3.2.2 to V4.0 format and pre-submission compliance inspection to avoid rejection by review authorities.

Backed by Dingkang’s integrated industrial chain covering raw material supply and full-cycle regulatory support, we resolve full-process registration obstacles from R&D to official approval for partners, helping you capture market opportunities amid the V4.0 submission reform era.

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