Asian Journal Of Social Pharmacy

Abstract: Objective To study the regulatory framework of advanced therapies in the European Union and the United States, and to provide reference for the regulation of cell- and gene-based therapeutic products in China. Methods The legal and regulatory documents, annual reports, work information and related literature published on the websites of the FDA and European Medicines Agency (EMA) were reviewed to analyze the regulatory models of advanced therapies in the European Union and the United States. Results and Conclusion the United States and the European Union have carried out a lot of work in the classification standards of advanced therapies, policy formulation and accelerated listing procedures. Therefore, they have established a relatively mature regulatory system. China can learn from their experience and continuously improve the regulatory system to help the sustainable development of gene and cell therapy industry.

Key words:  advanced therapy, gene therapy product, cell therapy product, European Union, USA