EN PL

MHRA: Preclinical Assessment of Investigational Cellular and Gene Therapy Products

06.12.2012
The diverse biology and clinical indications and the rapid and fluid state of the evolving scientific research into these product areas pose unique scientific challenges in terms of regulatory review. As a consequence the regulatory review process for evaluation of investigational CGT products necessitates a careful risk-benefit analysis performed in the context of the particular clinical indication under study.