BioCentury
ARTICLE | Politics & Policy

EMA clarifies advanced-therapy classification

July 1, 2014 1:30 AM UTC

EMA published a reflection paper on the classification of advanced-therapy medicinal products (ATMPs), or therapeutic products made from genes, tissue or cells. The optional classification helps sponsors identify applicable regulatory and development pathways and provides incentives such as fee reduction for scientific advice and certification of quality and non-clinical data by EMA.

The reflection paper clarified that ATMPs must contain recombinant genes or tissues or cells that have been "substantially manipulated." A combination product that contains a medical device and an active substance may also be considered an ATMP if the integral part of the product meets one of the ATMP definitions as a gene, cell or tissue product. ...