For the second consecutive year, the DIA China Annual Meeting was chaired by a renowned medical expert in China: Shun Lu, Director of the Center for Clinical Medicine of Lung Cancer, Shanghai Chest Hospital, Shanghai Jiaotong University. As a medical oncologist and clinical trial investigator, Lu has witnessed the unprecedented revolution in healthcare product development and regulatory reform in China, and how medical innovations have saved peoples’ lives. He called for collective action to find solutions for serving China’s aging society and to address challenges in drug innovation and development.

Keynote addresses were delivered by Tatsuya Kondo, Honorary Director of the National Center for Global Health and Medicine and former Chief Executive of PMDA, Japan; and by Yongjun Liu, Global Head of Research, Sanofi. Their remarks, respectively focused on regulatory science and the advancement of research and innovation, were a perfect prelude for two fundamental aspects that were discussed extensively throughout the conference.

Regulatory science is receiving increasing attention in China. In April 2019, the National Medical Products Agency (NMPA) launched its Regulatory Science Action Plan, with the following goals for the next three to five years: Establishing three to five new Centers for Regulatory Science; completing a series of research projects; and implementing new tools, standards, and approaches for product review and approval.

Regulatory science was also in the spotlight throughout DIA China 2019. Two of the eight DIAmond Sessions were focused on the regulatory science theme. Content in other sessions was carefully designed to reflect a variety of contemporary topics, from major global regulatory agencies reporting on their respective regulatory science strategies and initiatives, to regulatory issues surrounding gene and cell-based therapies, to the important local issues in China such as multi-regional clinical trials (MRCT) and using foreign clinical trial data to support product registration in China. For the very first time in China, the FDA, EMA, and PMDA all delivered an overview of their strategic goals and projects from the same stage. By advancing regulatory science, regulatory agencies have a unique ability to facilitate innovation and increase access to healthcare products.

The issuance of the guideline for accepting overseas clinical trial data for China registration presents a real opportunity to leverage MRCTs and other global development strategies such as accepting overseas data to accelerate product development and registration in China. Nevertheless, strategic and operational challenges remain. In a session on MRCT and use of foreign clinical trial data, a PMDA speaker reflected on the Japanese Agency’s evolution from the bridging strategy of ICH E5 to today’s MRCT strategy of ICH E17, while industry speakers from China shared their insights on the key determinants of strategizing simultaneous development based on global phase 3 trials. Their key take-home messages:

• MRCTs are one important way to address global health issues and facilitate new drug development.
• Overseas clinical trial data can be accepted and broadly applied in various drug development stages.
• However, specific data requirements should be defined on a case-by-case basis, and planned with regulatory and other health authorities through consultations early in the development process.