Abstract: Products of gene therapy, cell therapy and tissue engineering are defined as advanced therapy medicinal products （ATMP） by European Union. There are special rules to manage these products, including technical requirements, approval proposal, requirements for clinical trials and production. There were still no definite administrative regulations for these products in China. In this paper, the administrative regulations in European Union were introduced to provide some reference for our country.

Key words: Advanced therapy medicinal products, European Union, Administrative regulation