Environmental Risk Assessments (ERA) for Roche's Active Pharmaceutical Ingredients (API)

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The publication of environmental risk assessment (ERA) summaries is part of Roche’s engagement on developing a better understanding of issues regarding pharmaceuticals in the environment (PiE). New pharmaceutical substances are investigated for biodegradability and initial ecotoxicity during their development. For registration, a full state-of-the-art environmental risk assessment is developed based on chronic environmental effects and advanced environmental fate data, as required by the pertinent regulations. While not a regulatory requirement, Roche also investigates older pharmaceutical substances, normally at a simpler scale, in order to assess their environmental risks.

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