Europe: Draft TEP Guidance Issued
Posted 18 April 2012 | By
The European Medicines Agency (EMA) has issued a reflection paper intended to provide specific guidance on clinical testing for tissue engineered products (TEP), as well as cells or tissues combined with a medical device and considered a combined Advanced Therapy Medicinal Product (ATMP) and TEPs classified as a Gene Therapy Medicinal Product (GTMP).
A TEP may achieve a total or partial regeneration, repair and/or replacement, and EMA notes that the tissue functionality and structural aspects of the regenerated, repaired and/or replaced tissue as well as its during in the body are particular attributes of TEPs that should be taken into account when choosing clinical endpoints.
The reflection paper provides guidance on a number of topics involved in clinical testing of TEPs, including therapeutic claims, pharmacodynamics, pharmacokinetics, efficacy endpoints, trial duration, concomitant treatments and safety issues.
EMA - Reflection paper on clinical aspects related to tissue engineered products
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