Documents

Environmental Risk Assessment is regulated by the Guideline on the environmental risk assessment of medicinal products for human use and the Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs) and other, like e.g. Q&A, accompanying documents prepared by Committee for Medicinal Products for Human Use (CHMP). In general they focus on the exposure of the drug substance to environment (e.g. soil, surface and groundwater), its fate and effects in the environment (e.g. on algae, Daphnia, fish, microbes). Assessment of the potential risks to the environment consists of two phases and includes hazard assessment for persistence, bioaccumulation, toxicity (PBT) and calculation of the Predicted Environmental Concentration (PEC) followed by further analysis. If unclear of how to interpret guidelines or confused by calculations, our CMC Experts will surely help you with explanations!

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CAN YOU AVOID EXPENSIVE ENVIRONMENTAL TESTS?

Yes, there may be circumstances under which the absence of ERA studies may be justified. This is the case when a generic, hybrid or well-established use (WE) of medicinal product is introduced to the market. Nevertheless, an appropriate rationale should always be presented,

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WHY SHOULD YOU USE OUR EXPERIENCE?

Our Experts have deep knowledge because we have been looking at ERA from plethora of various angles, e.g. different product types, different substances, different procedure types and countries involved. If you wonder if ERA concerns your product and want to have ERA written by one of our Experts, you're welcome to contact us.

Would you like to know more? Need help in preparing ERA? Would you like our support to justify the lack of specific ERA studies?
Check our website or contact us directly.