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Eucomed responds over EU's hTEPS (human tissue engineered products) U-turn:

This article was originally published in Clinica

Executive Summary

Eucomed, the European medical device industry association, can accept that the overall regulatory framework for human tissue engineered products (hTEPs) is linked to the EU pharmaceutical legislation for the sake of speedy regulation. However, steps taken to ensure that any modifications to the Regulation on Medicinal Products for Human Use will appropriately take into account that hTEPs are NOT medicinal products. This is the official response of Eucomed, released as Clinica went to press, to the European Commission's proposal for a community Regulatory Framework on Advanced Therapies, the deadline for which was originally June 20, but was ultimately extended by one week. Clinica will cover more Eucomed detailed comments in issue No 1164.

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