As a result of new European Union legislation on the regulation of advanced-therapy medicinal products, EMEA has introduced the CAT. The CAT will play a central role in the assessment of innovative medicines based on gene therapy, somatic cell therapy and tissue engineering. These advanced medicinal therapy products promise to deliver ground-breaking new treatment options for patients suffering from serious diseases or injuries.

The CAT’s key role will be the preparation of a draft opinion on each advanced-therapy medicinal product submitted to EMEA for evaluation as part of a marketing-authorisation application, prior to the adoption of a final opinion by the Committee for Medicinal Products for Human Use (CHMP), which retains overall responsibility for scientific evaluation of human medicines at the EMEA.


For more information

please visit the EMEA website

Last modified on January 27 2009.