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European Commission spells out impact of advanced therapy products rule for industry and the public

This article was originally published in Clinica

Executive Summary

The days of increased transparency at the European Commission are clearly now here. The publication of the proposed Advanced Therapy Medicinal Products Regulation, covering human tissue engineered products (hTEPs), has been accompanied by a wealth of generally clear and unambiguous supporting information, writes Amanda Maxwell. Gone are the days when industry officials would struggle to understand the techno-speak and the rationale behind the regulations when they were first published. This proposal - only 23 pages long - is accompanied by a 10-page explanatory memorandum and a 15-page legislative financial statement, which grounds the proposed regulations in their real financial context.

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