U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Adv Exp Med Biol. 2023;1430:235-240. doi: 10.1007/978-3-031-34567-8_14.
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).
为了提高细胞和基因治疗产品的全球可及性，国际监管机构参与了一些项目，这些项目加强了监管机构之间的对话，为缺乏细胞和基因治疗监管能力的中低收入国家提供了培训机会，并支持监管要求的协调统一。本章概述了国际药品监管者协会（IPRP）细胞治疗工作组（CTWG）和基因治疗工作组（GTWG）、人用药品技术要求国际协调会议（ICH）以及亚太经合组织（APEC）监管协调指导委员会（RHSC）。此外，还讨论了被称为“讨论小组”和并行科学咨询（PSA）的小型监管机构之间的项目。
