Corporate Director, Global Health Policy Johnson & Johnson
Many policies, regulations, guidelines, standards and announcements in regulatory and clinical affairs have been introduced across the complete product life cycle from new submissions, modifications, renewals to post market surveillance. The Amendment of the major regulation -- Decree 680 is finally adopted, ushering in a new era where "easier access and stricter regulation" becomes possible. NMPA unveiled the first-of-its kind policies to allow importing unapproved drugs and medical devices to 2 geographic pilot areas: Hainan & Greater Bay Area (GBA). The Real-World Data, continuous implementation of China UDI system, the new e-filing system and AI guidance and more. With NMPA continuous reform, how can manufacturers or inventors be proactively prepared to shorten their time to market and stay up to date?