ATMP published and due to take effect by year end
This article was originally published in Clinica
Executive Summary
The EU's new Advanced Therapies Medicinal Products (ATMP) Regulation was published in the Official Journal of the European Union on November 13 and will take effect on December 30. The Regulation covers cell therapy, gene therapy and healthcare products containing viable human tissue-engineered products (hTEPs) and non-viable TEPs where the human tissue has a primary (rather than ancillary) action, under the pharmaceutical framework.