GMP Guideline for ATMPs

Today, the guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products was released by the EC. The new guidelines, developed after extensive consultation with stakeholders, EMA and competent national authorities, adapt the GMP requirements to the specific characteristics of ATMPs and address novel scenarios such as decentralised manufacturing, automated production, and reconstitution of ATMPs.

Guidelines on good manufacturing practice specific to advanced therapy medicinal products

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