News - December 1, 2025
EUCOPE Publishes White Paper on Strengthening ATMP Manufacturing in Europe
EUCOPE’s Cell & Gene Therapy Working Group has published a new White Paper on ATMP Manufacturing, outlining the key barriers that innovators face in bringing advanced therapies to patients across Europe and proposing concrete solutions to strengthen Europe’s biomanufacturing landscape.
The paper identifies five critical challenge areas—from limited manufacturing capacity and inconsistent regulatory standards to constraints linked to raw materials, GMO legislation, and workforce shortages—and sets out 23 policy recommendations to support a competitive and innovation-friendly ATMP ecosystem.
Among its core proposals, the White Paper calls for:
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modernised, ATMP-specific regulatory and manufacturing guidelines;
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a fit-for-purpose framework for decentralised and Point-of-Care manufacturing models;
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streamlined approaches to cross-border manufacturing and import testing;
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improved harmonisation and risk-based reforms to the GMO framework;
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targeted investment in skills, training, and digitalisation across the manufacturing chain.
As the EU advances the Biotech Act, the General Pharmaceutical Legislation, and its broader Life Sciences Strategy, the White Paper highlights a pivotal opportunity to ensure Europe remains a globally competitive region for ATMP development, production, and clinical application.
Download the White Paper here.