From Paper to Pixels: China’s Progress in Drug Registration Digitisation

The electronic Common Technical Document (eCTD) is a standardised format for regulatory submissions in the pharmaceutical industry, facilitating the efficient exchange of information between regulatory authorities and pharmaceutical companies. China’s commitment to international regulatory harmonization is evident in its gradual adoption of eCTD since joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We will provide a comprehensive overview of China’s eCTD journey, highlighting significant milestones, challenges, and future trends.

Early Adoption and Challenges

China’s journey towards eCTD began with the adoption of the Common Technical Document (CTD) format. In 2010, the National Medical Products Administration (NMPA) issued a notice requiring the submission of chemical drug registration data in CTD format. However, the transition to eCTD posed several challenges, including technical complexities and resource constraints, particularly for smaller pharmaceutical companies.

Key Milestones and Policies

China’s eCTD adoption has been marked by several key milestones and regulatory changes:

• 2017: NMPA joined ICH, marking a significant step towards international regulatory harmonization. The Center for Drug Evaluation (CDE) initiated various activities, including eCTD project discussions, software development meetings, and training sessions for industry representatives.
• 2018: The NMPA issued a notice aligning with ICH guidelines, requiring the submission of registration applications for certain drug categories in CTD format.
• 2019: Progress continued with the solicitation of feedback on eCTD technical specifications, validation standards, and submission guidelines.
• 2020: The release of China’s “Module 1” administrative documents marked a significant milestone in eCTD implementation.
• 2021: The NMPA announced the implementation of eCTD for specific drug categories, with a transition period requiring both electronic and paper submissions.
• 2022: The NMPA mandated paperless submissions for drug registration applications, further advancing eCTD adoption.
• 2024: The CDE introduced software for electronic submission preparation and announced the trial of network-based submission methods, akin to the FDA’s Electronic Submission Gateway (ESG).

Industry Response and Adoption

The adoption of eCTD has varied among pharmaceutical companies. Multinational corporations (MNCs) and top domestic firms have been early adopters, participating in pilot programs and investing in eCTD systems. However, smaller companies have faced challenges, such as system integration, data management, and training. Support mechanisms, including training sessions and software solutions, have been provided to facilitate the transition.

Current Status and Future Outlook

China’s eCTD implementation is progressing steadily, with increasing adoption among pharmaceutical companies. Future trends include the expansion of eCTD to other regulatory activities and the potential adoption of newer eCTD versions. The transition from paper to digital submissions is expected to enhance efficiency, improve data quality, and facilitate collaboration between regulators and industry stakeholders.

China’s journey towards eCTD adoption has been marked by significant milestones and challenges. The benefits of eCTD adoption, including increased efficiency and improved data quality, are evident for both regulators and industry stakeholders. As China continues to advance its eCTD implementation, potential challenges may arise, but with strategic planning and support, the transition to a fully digital regulatory environment is within reach.

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