EMA Releases Draft Reflection Paper on Tissue Engineered Products
Posted 17 April 2012 | By
The European Medicines Agency (EMA) released a draft reflection paper on tissue engineered products (TEPs) and how to best conduct clinical trials to prove their safety and efficacy.
TEPs are "innovative and complex medicinal products intended to regenerate, repair or replace human tissue," and EMA notes some clinical studies-particularly those evaluating safe dosing and general safety-may be challenging.
EMA's 17 April Draft reflection paper on clinical aspects related to tissue engineered products aims to "provide specific guidance on clinical testing for tissue engineered products as defined in Regulation (EC) No 1394/2007."
EMA's reflection paper discusses various consideration that go into the clinical testing of TEPs, including regenerative properties, therapeutic claims, pharmacodynamics, setting parameters for the study, optional pharmacokinetic studies, efficacy endpoints, dosing, blinding, comparator studies, trial duration, safety considerations and surgical procedures.
EMA - Draft reflection paper on clinical aspects related to tissue engineered products