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Eucomed fights for stand-alone regulation for HTEPs

This article was originally published in Clinica

Executive Summary

A stand-alone new European regulation is necessary for human tissue-engineered products, or European industry will suffer globally. That is the statement that has been made by Eucomed, following the circulation of reports that HTEPs are to be regulated alongside pharmaceuticals and that the so-called "third pillar" of regulation, a unique regulatory framework for these products, has been abandoned (see Clinica Nos 1151, p 3 1153, p 3).

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