The cell and gene therapy products are being developed at a very fast pace with the introduction of new technologies and research. Due to their complicated development phases, the regulators are closely monitoring safety and efficacy of these products. The regulators, EMA and FDA, are facilitating the ease of market approvals of such products and have developed special programs for the benefit of sponsors and patients.
This whitepaper focuses on the comparison of regulatory framework, covering a glimpse of regulations, approval pathways, and various incentives related to cell and gene therapy products in the European Union and the United States.