Titlebook: Regulatory Aspects of Gene Therapy and Cell Therapy Products; A Global Perspective Maria Cristina Galli Book 2023Latest edition The Editor(

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The Regulation of Cell Therapy and Gene Therapy Products in Switzerland,roducts, Swissmedic, is the lead Regulatory Authority and its ATMP Division is responsible for the regulation of these products at the level of clinical trials and marketing authorization. CGTPs are regulated similarly to medicinal products. The legal basis is set by the Therapeutic Product Act, the

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United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies,for these products to treat diverse, often rare, clinical indications is promising. The Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER) at the United States Food and Drug Administration (US FDA) is responsible for the regulation of these products, amon

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Canadian Regulatory Framework and Regulatory Requirements for Cell and Gene Therapy Products,nt regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene t

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Advanced Therapy Products in Brazil: Regulatory Aspects,ular therapy products, tissue engineering products, and gene therapy products, which due to their complexity involve innovation and risks, optimized regulatory channels for their development and life cycle monitoring. The scientific elements and the compliance with applicable regulatory aspects are

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Regulation of Clinical Research for Cellular and Gene Therapy Products in India,utic products. The US-FDA refers to this category of products as Cellular and Gene Therapy Products (CGTPs), while the European Medicines Agency, Europe, refers to them as Advanced Therapy Medicinal Products (ATMPs). The research and development (R&D) and final commercialization of these products ha

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