Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012.
Following the Regulation EC) No 1394/2007 the "Advanced Therapy Medicinal Products (ATMPs) Regulation", European Medicines Agency and European Commisison determine whether or not a given product meets the scientific criteria which define ATMPs. For clarifying the status of such a product applicants have access to an optional procedure which is the CAT (Committee for Advanced Therapies) scientific recommendation for the classification of ATMPs. This procedure would be useful for the Agency as well as for the applicants to evaluate the status of the product.
The ATMP classification is based on the evaluation of whether a given product fulfils one of the definitions of gene therapy medicinal product (GTMP), somatic cell therapy medicinal product (sCTMP) or tissue engineered product (TEP) and whether the product fulfils the definition of a combined ATMP or not. However, it is also acknowledged that, due to the complex nature of these therapeutic products, the limited data package at an early stage of product development and the rapid evolution of science and technology, questions of borderline may arise.
The classification should help the developers to identify the applicable regulatory framework and furthermore the development path and the scientific-regulatory guidance to be followed. Amongst this, it will be helpful in the dialogue with the regulators and to determine whether, depending on the type of product, liaison with other committees such as Committee for Orphan Medicinal Products (COMP) and/or Paediatric Committee (PDCO) may be recommended to the applicant.
Please see the complete "Reflection paper on classification of advanced therapy medicinal products" with the executive summary, the discussion and the references for further information.
Please pay attention to ECAs new workshop on "GMP for Advanced Therapy Medicinal Products", on 12 October 2012 in Heidelberg, Germany.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)