Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan.

ABSTRACT: Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the definition, legislation, and approval system of these products were surveyed. A total of nine autologous human cells and tissue products approved until October 2013 were collected. The definitions of human cells and tissue products were compatible among the US, the EU and Japan. The products were classified as human cells, tissue, and cellular and tissue-based products (HCT/Ps) in the US, advanced therapy medicinal products (ATMPs) in the EU, and cell/tissue-engineered products in Japan. These product

SUBMITTER: Yano K 

PROVIDER: S-EPMC6581762 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature