Meeting Highlights: DIA China Annual Meeting 2022
China Applications for Clinical Trials and Drug Registration Must Now Be Electronic
Highlights and Impact
DIA 2022
Handsome Ji
Pfizer China R&D Center
Wen Yin
Pfizer China R&D Center

ffective January 1, 2023, in accordance with the requirements of the NMPA Announcement (No. 110, 2022) on the Implementation of Electronic Submission for Drug Registration (Chinese only) released on November 30, 2022, all regulatory submissions for clinical trial applications, new drug applications, and all supplementary dossiers thereto must be submitted in electronic format. Applicants may no longer submit any paper documentation.

This new regulation is another demonstration that China is embracing the new era of comprehensive electronic transformation for drug registration, including acceptance of electronic dossiers, issuing electronic administrative acceptance documents, and electronic document review. In addition, this regulation moves China one step closer to full implementation of the electronic common technical document (eCTD) for drug registration, which has been shown to significantly improve the efficiency of both dossier execution and regulatory review. It also shows that China’s regulator is accelerating improvement of its regulatory review and approval technology to meet international standards, which will further bring more convenience to applicants submitting multiple global drug applications simultaneously.

Highlights of Electronic Submission for Drug Registration

1) Electronic, paperless dossier
All regulatory submissions for clinical trial applications, new drug applications, and supplementary dossiers must be submitted in electronic format as of January 1, 2023. From this date forward, regulatory submissions will be paperless. Applicants who previously submitted in eCTD format will not need to also submit a paper dossier after the release of the announcement (on November 30, 2022).

2) Electronic administrative acceptance documents
Mailing of paper administrative acceptance documents is replaced by transmittal of electronic versions of these documents through the Drug Application System and eCTD Drug Registration System in real time. Both have the same legal effect as the previous paper versions.

3) Electronic signatures
Inclusion of electronic signatures of the applicant or the authorized registration agent for all .pdf files in the drug application dossier is mandatory.

Impact of Electronic Submission on Drug Registration

1) Electronic submissions bring more efficiency and convenience to both the Center for Drug Evaluation (CDE) and to applicants in the processes of document creation, transmission, review, archiving, retrieval, reuse, and lifecycle management, significantly improving the overall efficiency of dossier execution, submission, and regulatory review.

2) Electronic submissions impose higher requirements on the applicant’s deployment of their existing personnel, systems, and processes to meet the needs of electronic submission.

Higher quality standards and changing processes to prepare and implement electronic application dossiers can make electronic submissions challenging for many applicants. Applicants must respond to these changes and challenges by training their regulatory affairs operations and other staff, and by refining their existing systems and processes, to meet the different requirements for electronic submission.

For example:

  • In the early stage of document preparation and writing, applicants should pay attention to format compliance, template development, utilizing writing plug-ins, and establishing a quality-control process to ensure that all documents meet submission standards of compliance and readability before finalization.
  • In the middle and later stages of writing and publishing, applicants should leverage the eCTD verification software to validate and ensure that all file sizes and path lengths conform to technical requirements.
  • Finally, applicants must establish a new internal management process for electronic signatures, applying and validating electronic signatures for all .pdfs, and then burning all data onto the hardcopy CD/DVD submitted to CDE to support their electronic application dossier, after final virus inspection.

Applicants should comprehensively improve their technologies that support document writing, management, and publishing, and must consider the new electronic signature process before planning the application process, timeline, and staff deployment.

3) Electronic submissions simultaneously improve the work efficiency of regulatory affairs operations staff and the relevant skill sets required to support electronic submission.

Regulatory affairs operations staff must a) learn the relevant new requirements, laws, and regulations for electronic submissions; b) conduct more practical training on, and become more familiar with, related software and systems such as writing templates and plug-ins, .pdf processing software, and the eCTD publishing and electronic document management systems; and c) improve their skills in preparing, publishing, and managing standardized submission-ready documents, all toward the goal of preparing a high-quality application dossier that can be efficiently reviewed.

Electronic submissions are undoubtedly the future; in fact, they are here now. Applicants should seize this opportunity to contribute to the acceleration of regulatory review and approval, which will make more new drugs more quickly accessible and beneficial for patients in China.