CDE Proposes New Communication Guidelines for Advanced Therapy Medicinal Products to Accelerate Review Process

On September 8, the Center for Drug Evaluation (CDE) of the National Medical Products Administration released the “Detailed Rules for the Application and Management of Type I Communication Meetings for Advanced Therapy Medicinal Products (ATMPs) (Draft for Comment),” proposing to establish a rapid communication mechanism for three categories of innovative therapies, thereby significantly reducing review waiting times.Accelerating the Innovative R&D of Advanced Therapy Medicinal Products, Including Cell and Gene Therapies, in China。