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hTEPs (human tissue-engineered products): "dedicated response within pharma framework needed"

This article was originally published in Clinica

Executive Summary

If human tissue-engineered products (hTEPs) were to fall under the EU's medicinal products regime, subject to most of its requirements, then there would be serious concerns for the industry dealing with these technologies. But if the Commission is designing a dedicated and independent regulation that will introduce specific customised requirements to demonstrate the quality, safety and efficacy of hTEPs and other advanced therapies under a pharmaceutical regulatory umbrella, then there should be no reason to object.

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