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EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients

Executive Summary

The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.

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PIC/S Proposes Specific GMP Annex For Advanced Therapies

Authorities from the international Pharmaceutical Inspection Co-operation Scheme have suggested splitting the existing Annex 2 of the PIC/S good manufacturing practice guide in a bid to resolve divergences with the EU ATMP manufacturing guide.

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.

Not There Yet: Concerns Persist On Appropriate Format Of EU GMP Guide For ATMPs

After holding two rounds of public consultation on its proposals for good manufacturing practice requirements for advanced therapy medicinal products, the European Commission has still not been able to address stakeholder concerns regarding the appropriate format of this eagerly-awaited draft guideline.


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