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EMEA: Concept paper on the need to revise the guideline on the use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human use

27.07.2009
The current guideline was prepared at a time when the scientific possibilities for transgenic animals were being investigated and no product had been generated for commercial or clinical trial purposes. In addition, many relevant guidelines, such as the ICH Q5 series had not been prepared.