The Need for Non-Human Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017)

Published by EC

Non-Human Primate Model

EU opinon and legilastion on the suse of Non-human Primate in Biomedical Research. The European Commission strongly advocates the “3Rs principle”. now a legal obligation embedded in the EU legislation to: Replace non-human primates with viable alternatives whenever feasible, Reduce the use of non-human primates and Refine scientific procedures and the care and treatment of the animals

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This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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