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Wider Gene Therapy Definition In EU Will Require ‘Myth-Busting’ From EMA

 
• By Eliza Slawther

The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.

(Shutterstock)

A widening of the definition of a gene therapy medicinal product (GTMP) is among the many changes proposed in draft legislation, which once finalized, will reform the EU pharmaceutical legislation.

As it stands, the draft text will see an “all-encompassing definition” introduced for GTMPs, said Christian Schneider, of the pharmaceutical...

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