EMA Releases New Guidance on Stem Cells Medicines
The European Medicines Agency has released new guidance covering the different types of stem cells used in medicines.
The European Medicines Agency has released new guidance on medicines based on stem cells. The guidance covers the different types of stem cells used in medicines, and the considerations that pharmaceutical companies need to take into account when developing medicines including stem cells or developed from stem cells.
The reflection paper on stem cell-based medicinal products stresses the fact that companies developing medicines including stem cells need to pay close attention to the way the medicines are manufactured, to make sure that the final medicine is as consistent and reproducible as possible.
Pre-clinical and clinical testing also needs to take account of the cells' properties, ensuring that the possible risks of tumou
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