The EMA requires that an Environmental Risk Assessment (ERA) accompany every Marketing Authorization Application (MAA) for a new pharmaceutical. Likewise, the US FDA stipulates that a Risk Assessment or Categorical Exclusion claim accompanies every IND, NDA or BLA.
Guidelines follow a risk-based tiered approach based on environmental release of the pharmaceutical, with testing dictated by partitioning, solubility, PBT characteristics, and endocrine activity.
Smithers has provided pharmaceutical companies of all sizes with impact assessment in the pharmaceutical industry for EU and US submissions over 250 drugs.
- Physical Chemistry / Environmental Fate:
- Water solubility, dissociation constant (pKa), Partition coefficient (KOW), Adsorption coefficient (KOC)
- Full EU Phase 1, Phase II Tier A and B testing
- Full US FDA coverage
- Study design and regulatory consultation
- Acute / chronic, aquatic / terrestrial ecotoxicology capabilities
- Risk Assessment or Categorical Exclusion reports
View a summary of the February 2021 SETAC Pharmaceuticals Interest Group session
on regulatory practices related to pharmaceuticals in the environment (PiE).