The European Commission has at last finalized the long-awaited guideline on good manufacturing practice (GMP) requirements for innovative cell, gene and tissue therapies - also referred to as advanced therapy medicinal products (ATMPs).
European Commission Finally Delivers On GMP Standards For ATMPs
Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.
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