eCTD Compilation and Submission

eCTD (electronic Common Technical Document) is an electronic format used for drug registration and evaluation. It organizes, transmits, and presents drug submission materials that comply with the Common Technical Document (CTD) specification using Extensible Markup Language (XML). eCTD simplifies the preparation, submission, acceptance, evaluation, lifecycle management, and archive storage of submission materials. It ensures the quality of submissions, enhances the efficiency of evaluations, and, most importantly, maintains global uniformity and consistency in the format, content, and standard requirements of submission materials.

The use of eCTD for submitting drug registration materials has become a consensus among major drug regulatory agencies worldwide. The U.S. FDA made it mandatory for marketing applications to be submitted through eCTD starting in May 2017, gradually expanding the scope to include other applications such as commercial INDs. China's NMPA also officially implemented eCTD on December 29, 2021, applicable to Class 1 and 5.1 chemical drug registrations, as well as Class 1 therapeutic and prophylactic biological product registrations. In summary, eCTD submission and publishing have become indispensable components of the drug registration process.

What Can Humphries Do

Humphries established its own eCTD system as early as 2013, utilizing the docuBridge system from the German company LORENZ, which is used by 13 drug regulatory agencies, including the U.S. FDA and China's National Medical Products Administration (NMPA), as well as over 1700 global enterprises.

Humphries's eCTD team is well-versed in the latest regulatory requirements and has extensive practical experience in eCTD operations. Through stringent internal quality control and efficient external client communication, our eCTD services ensure the quality and compliance of submission documents while saving submission time. Humphries completes over 300 eCTD submissions to the FDA annually, covering various types such as INDs, IND maintenance, NDAs, BLAs, ANDAs, DMFs, etc., without ever receiving a rejection notice from the FDA.

01. Compliance Adjustment/Review of Documents

Humphries's regulatory submission team or the Sponsor provides finalized submission materials according to the CTD directory structure and document granularity requirements. Humphries's eCTD team adjusts the compliance of each document and conducts at least two rounds of checks based on regulatory requirements and eCTD technical specifications. This includes handling more than 50 items for Word/PDF electronic documents, such as bookmarks, tables of contents, hyperlinks, font embedding, initial view settings, etc., ensuring that the electronic documents for submission meet regulatory requirements and are reviewer-friendly.

02. Document Assembly

Document assembly is performed in the professional eCTD client system, docuBridge. Humphries's eCTD team constructs eCTD structured documents in accordance with relevant regulations and eCTD technical specifications. This includes document format checks, attribute settings, the creation of study tag files (STF), filling in information metadata, creating external links, and other operational steps. The final eCTD-structured documents are generated to ensure error-free document assembly. Each submission undergoes at least two rounds of checks by different eCTD specialists to guarantee the accuracy of document assembly.

03. Document Verification and Publishing

After the completion of document assembly in eCTD structured format, Humphries's team verifies the assembled materials within docuBridge. If the verification is successful, the eCTD submission materials will be published through the FDA Electronic Submission Gateway (ESG). If the verification fails, the materials will be refined based on the verification results until successful verification is achieved.

04. Lifecycle Management

Lifecycle management is a crucial concept in eCTD submissions. Due to the lengthy process of drug development, Sponsors need to continuously revise, change, or add documents submitted, such as information supplements after the initial IND submission (Information Amendment), annual reports, safety reports, product correspondence, etc., as well as various supplementary applications and changes after drug market approval. Humphries's team is familiar with document preparation and lifecycle management for various submission types, ensuring that the eCTD submission and maintenance processes comply with regulations and standards.