Abstract: The necessity of a consistent approach and a regulatory "memory"
was addressed by the EU with the promulgation of the Regulation 1394/2007/EC
and the creation of a new committee for the evaluation of the Marketing
Authorisation Application (MAA) of ATMPs, the Committee for Advanced Therapies
(CAT). However, the scientific background of the ATMPs is rapidly changing due
to a high rate of innovation. In fact, often the time frame required to perform
the clinical development, usually of at least 5 years, is such that the product
or some of its assumption might be obsolete at the moment of the Marketing
Application. To favour the Small and Medium Enterprises (SMEs) and academic
sponsors, the Regulation contains provisions which are intended to help this
transition and to smooth the regulatory hurdles.
Keywords: ATMP, CAT, EMA, preclinical data certification, clinical studies