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EMA: EMA publishes Document on the Validation of analytical Methods

14.08.2014
The European Medicines Agency (EMA) published the concept paper \"Transferring quality control methods validated in collaborative trials to a product/laboratory specific context\". To accept a method an authority always requires a scientific validation. The same applies when existing methods are to be replaced, reduced or to be optimized (3R = replacement, reduction, refinement). Many of these new methods principally represent an improvement compared to the old \"standard\" methods and therefore are acceptable from a regulatory perspective.