Environmental Risk Assessment

Since 2006, an Environmental Risk Assessment (ERA) is required for all new marketing authorization applications (MAA) for medicinal products, including those for generics.

ToxHub has extensive experience and knowledge in risk assessments and offers comprehensive services in the field of environmental risk consulting for human and veterinary drugs. The Environmental Risk Assessment (ERA) service from ToxHub is based on the European guideline on the environmental risk assessment of medicinal products for human use and includes the following services:

  • Environmental Risk Assessment (ERA) of pharmaceuticals, Phase I, according to the EMA guideline on the Environmental Risk Assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00), and relevant Q&A (2010 and 2011):
    • Comprehensive literature search using public and commercial databases;
    • Estimation of environmental exposure; Persistence, Bioaccumulation and Toxicity (PBT); calculation of the initial Predicted Exposure Concentration (PEC);
    • Possible refinement of the market penetration factor (Fpen) based on market data;
    • Data gap analysis under consideration of non-testing approaches;
    • Identification of intelligent testing strategies, design and management of testing programmes;
    • Derivation of M-factors;
    • ECHA-guideline compliant assessment of endocrine disrupting properties.