Whither advanced therapy medicinal products

The topic of this special issue of Transfusion Medicine and Hemotherapy is advanced therapies and tissue engineering. The legislative framework that regulates these fields in Europe is based on two Directives (and their amendments) of the European Commission [1, 2] and has been legally binding in all EC member states since December 2008. The term Advanced Therapy Medicinal Products (ATMPs) is generally used to refer to the legislation. The regulations were introduced at a time when many regenerative therapies seemed close to translation into clinical practice. However, the level of success with the translation of gene- and cell-based therapies has not met the expectations of the pre-ATMP era. It has been argued that the demands of the regulatory framework may have contributed to a degree of stagnation in the field, but it is difficult to quantify to what extent the ATMP guidelines have hindered progress. This foreword reviews pertinent aspects of the ATMP directives, summarizes the current landscape with respect to approvals (granted and pending), and discusses public domain information relating to withdrawal of applications for marketing authorization. It would appear that the ATMP regulations will need to evolve if the promise of regenerative medicine is to become a clinical reality.