China issued Order 818 establishing a new commercialization pathway for advanced therapeutic development, including cell and gene therapeutics and gene editing approaches. The regulation allows certain mechanisms of action at the cellular or molecular level to be translated clinically at 3A hospitals without requiring National Medical Products Administration (NMPA) drug registration. Under the translational approval step, hospitals can begin charging patients for the treatments after the approved observation window and required oversight. The policy is designed to standardize development in a way that accelerates local innovation and production, particularly for therapies that are difficult to route through conventional investigational and registration frameworks. Contract and milestone terms may require review for international partners already working in China, since the new pathway changes where development work sits in the regulatory timeline and how commercialization can proceed domestically. Order 818 became effective May 1.