The Pilot Phase of eCTD in China's market

China has implemented the eCTD format for all applications starting January 2023, eliminating the need for paper submissions. The events and timelines leading to the eCTD implementation are briefly mentioned below;

• 2015: Regulatory Reform – eCTD Initiation by CDE
• 2017: Draft eCTD structure document for public comment & submission guidance. China accepts ICH standards.
• 2018: Tender process initiated for eCTD system build
• 2019: Draft eCTD submission guidance released for public comment. Draft technical specs & verification standards released.
• 2020: CDE released 2nd draft technical specs & verification standards.
• 2021: NPMA releases formal notice for eCTD implementation of 29/12/2021.
• 2022: CDE releases adjustments required during the pandemic.
• 2023: As of 01/2023, All applications are accepted in eCTD format, with no need for paper.
• 2024: The following documents have become effective March 1, 2024: Technical Requirements for Compact Disks Containing Application Dossiers, Electronic Common Technical Document (eCTD) Structure, and eCTD Validation Criteria. Trial submission of eCTD via network transmission has been made available on July 1, 2024.

Overall, the updates listed above aim to enhance the efficiency and effectiveness of the drug registration process in China, while aligning it with international standards and improving the overall regulatory environment.

The key challenges with the new updates for electronic submission of drug registration applications in China include:

1. Transition to eCTD Format: Moving from paper submissions to the eCTD format requires significant changes in the submission process and may involve a steep learning curve for the teams involved.
2. Adherence to ICH Standards: Ensuring compliance with the latest technical requirements of ICH Standard 3.2.2 can be challenging, especially for organizations that are unfamiliar with these standards.
3. Bilingual Submissions: All submissions must be bilingual in Chinese and the original language, with both versions fully navigational, requiring additional resources for translation and validation.
4. Electronic Seal Requirement: Implementing electronic company seals for cover letters and application forms, validated by Health Authorities, adds another layer of complexity to the submission process.
5. Network Transmission: The trial implementation of submitting electronic application materials via network transmission starting July 1, 2024, may pose technical challenges for some.
   These challenges highlight the need for thorough preparation and collaboration across various departments to ensure a smooth transition to the new submission requirements.

Several strategies can help navigate the challenges of implementing the new electronic submission requirements for drug registration in China:

1. Training and Education: It is crucial to provide comprehensive training and education to the teams involved in the submission process. This includes familiarizing them with the eCTD format, ICH standards, and the specific requirements for bilingual submissions and electronic seals.
2. Collaboration and Communication: Encouraging collaboration and open communication between departments, such as regulatory, IT, and translation teams, can help ensure a smooth transition. Regular meetings and updates can keep everyone aligned and address any issues promptly.
3. Investing in Technology: Upgrading IT infrastructure to support network transmission and electronic submissions is essential. This includes ensuring robust cybersecurity measures to protect sensitive data and investing in software that can handle the eCTD format and bilingual submissions.
4. Engaging with Health Authorities: Maintaining a close relationship with health authorities and seeking their guidance can help navigate the new requirements. This includes understanding the validation criteria for electronic seals and ensuring compliance with all regulatory guidelines.
5. Resource Allocation: Allocate sufficient resources, including personnel and budget, to manage the transition effectively. This may involve hiring additional staff or outsourcing specific tasks, such as translation, to ensure timely and accurate submissions.

By implementing these strategies, organizations can better manage the challenges posed by the new updates and ensure a successful transition to the latest submission requirements.

ProductLife group has all the resources and tools to help your business transition to eCTD in China. An experienced publishing team, a translation team that can help you in almost any language, an eCTD tool ready to publish in the correct format, and the know-how needed to make everything as easy as possible.

Fadime Kale
Program Director