On September 1, 2025, Shenzhen News - CPHI&PMEC Shenzhen Pharmaceutical Industry Exhibition officially kicked off at the Shenzhen Convention and Exhibition Center. Although the overall scale of this year's exhibition has been reduced, the "Third Greater Bay Area Pharmaceutical Industry Manufacturing 4.0 Forum" jointly organized by the Guangdong Pharmaceutical Engineering Association and CPHI still attracts the attention and participation of many industry professionals with its professionalism and foresight.
The forum focuses on pharmaceutical industry 4.0, including topics such as smart factory practices, analysis of international regulatory policy hotspots, and AI pharmaceutical applications, gathering 11 industry experts to share. The content closely follows the practical needs of digital transformation in the pharmaceutical industry, providing valuable industry insights and practical references for attendees.
Ms. Tracy Feng, vice general manager of gempex China and senior GMP expert, was invited to give a keynote speech on "Technological Trends and Regulatory Logic of Pharmaceutical Intelligent Manufacturing" at the forum.
She started from the evolution of global intelligent manufacturing and specifically introduced that among the 189 "lighthouse factories" in the world, the pharmaceutical and medical device industry has already occupied 23 seats, of which 3 new ones have been added in China in the past two years (Johnson&Johnson Xi'an, AstraZeneca Wuxi, General Electric Medical Beijing), indicating that China's pharmaceutical industry 4.0 is rapidly advancing. At the regulatory level, Ms. Feng compared domestic and international policy trends and pointed out that with the release of the EU's first GMP Appendix 22 "Artificial Intelligence" draft and the promotion of China's "Implementation Plan for the Digital Transformation of the Pharmaceutical Industry (2025-2030)", there will be more and more regulations and guidelines related to AI, and regulatory trends will become more perfect and strict.
In her speech, Ms. Feng not only interpreted the application examples of AI in the entire lifecycle of drug research and development, production, supply chain, and post market monitoring, but also shared the compliance strategies of DeEn Consulting in helping enterprises cope with cross-border compliance and smart factory upgrades. The on-site audience focused on listening, reflecting the industry's high attention to intelligent manufacturing and cross-border compliance issues.
