TWO EUROPEAN PHARMA REGULATORS COMBINE EFFORTS ON CELL-BASED AND GENE THERAPY PRODUCTS
November 3rd, 2013
THE EUROPEAN Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and HealthCare (EDQM) have joined forces to promote quality standards for manufacturing cell-based and gene therapy pharmaceuticals. The two bodies have staged a joint symposium on the difficulty of securing suitable information about the quality of raw materials, increasing the difficulty of assessing their impact on medicine quality and safety.Topics discussed included what quality attributes are important for raw materials, and relations between manufacturers and ...
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