International Harmonization for Cell and Gene Therapy Products

To increase the global availability of cell and gene therapy products, international regulatory agencies engage in programs that enhance dialogue between regulators, provide opportunities for training low- and middle-income countries lacking the capacity for regulatory oversight of cell and gene therapies, and support harmonization of regulatory requirements. This chapter provides overviews of the International Pharmaceutical Regulators Programme (IPRP) Cell Therapy Working Group (CTWG) and Gene Therapy Working Group (GTWG), the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Asia Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC). Also discussed are programs between small groups of regulators referred to as "Discussion Clusters" and Parallel Scientific Advice (PSA).