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Pharmaceuticals in the Environment (PiE) update
The Inter-Association Initiative Task Force on Pharmaceuticals in the Environment (IAI PiE TF) – formed of AESGP, EFPIA and MfE – has released the final Technical Guidance on Manufacturing Effluent Management and the Extended Environment Risk Assessment (eERA) Position Paper. These documents are available on the Eco-Pharmaco-Stewardship page of AESGP website.The IAI PiE TF Advocacy Team is working to develop shorter versions of the documents for advocacy purposes and for bringing them to European level policy makers.The Responsible Manufacturing Effluent Management Technical Guidance provides internal guidance to companies and their suppliers to help them identify and mitigate the potential impacts of API in wastewater from manufacturing operations. It provides flexibility for existing approaches while ensuring there is agreement on key methodological decision. It also provides a risk-based approach, i.e. the degree of rigor should vary with the risk posed by the APIs to the environment. AESGP has also shared the IAI Responsible Manufacturing Effluent Guidance webinar slides.The extended ERA (eERA) approach is designed to address challenges and strengthen the ERA process in the EU and the eERA will aim to provide several benefits such as increasing the transparency of, and access to, ERA data in order to avoid duplication of animal testing.
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