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

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.

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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.

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