EMA: Reflection paper on classification of advanced-therapy medicinal products

The aim of this reflection paper is to introduce the advanced-therapy medicinal product (ATMP) classification procedure by means of clarifying the legal basis for ATMP classification, providing clarification on the grounds applied for the classification of ATMPs, providing further clarification on the information to be submitted by applicants for the purpose of the ATMP classification and communicating the current status of discussions on some borderline cases and on selected areas where scientific knowledge is fast evolving or experience is limited.