We were honored to participate in the 2025 China (Suzhou) Innovative Pharmaceutical Medical Conference and CMAC Annual Meeting, held from March 18-20. The event, under the theme "Harnessing New Medical Knowledge, Uniting Innovation Power", brought together leading global experts to explore the latest in drug development and clinical value.
A key highlight was the eCTD International Vision & China's Next Steps forum, where Richard Que, Willingjet Life Science’s Regulatory Operation Service Lead, shared his expert insights on the expansion of eCTD implementation in China. Richard emphasized the increasing significance of eCTD in drug submissions and outlined essential strategies for companies navigating the evolving regulatory landscape.
Expanding eCTD Scope in China: Richard highlighted how the scope of eCTD in China is set to expand, with pharmaceutical companies facing both challenges and opportunities as they adapt to this change.
Balancing Preparation and Implementation: He addressed two common mindsets in the industry: one that fears eCTD submission as overly complex, and another that assumes it’s easy and requires no preparation. Richard advised that companies should strike a balance, leveraging international and domestic experience while preparing thoroughly for the transition.
Practical Steps for Companies:
1.Strengthen eCTD Knowledge: Regardless of whether you build an in-house team or use outsourcing services, it’s crucial to enhance your team’s eCTD expertise to ensure smooth submission processes.
2. Conduct Hands-On eCTD Practice: Richard emphasized the importance of practical experience—starting with appropriate products to familiarize teams with the eCTD submission process.
3. Ongoing Optimization: After the initial submissions, it's vital to review the process, learn from any challenges, and continuously refine submission strategies.
Richard's thought leadership on eCTD implementation resonated deeply with attendees, providing valuable guidance for companies aiming to stay ahead in China’s evolving regulatory environment.
About CMAC Conference: The CMAC conference, hosted by the China Pharmaceutical Innovation and Development Association, is a key platform for high-level discussions on pharmaceutical regulation, drug research, clinical trials, and global registration. It attracted thousands of industry professionals, reinforcing its position as one of China’s most influential pharmaceutical events.
About Willingjet Life Science:Willingjet Life Science is a leading provider of pharmaceutical information solutions and eCTD services, dedicated to supporting pharmaceutical companies with regulatory compliance and international expansion goals.
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