Regulatory considerations for decentralized manufacture of ATMPs

Decentralized manufacture (DCM) has the potential to facilitate uptake of advanced therapy medicinal products (ATMPs) within the EU. The new GMP guideline for ATMPs contains welcome new flexibility in regard to DCM and also in relation to use of automated equipment. However regulatory challenges extend beyond GMP issues, including questions of comparability of product manufactured at multiple hospital sites and mechanisms for introduction of new sites within the current variations framework. The need for additional guidance from regulators is discussed.

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