Regulatory Update – Pharmaceuticals in the Environment
View a summary of the SETAC Pharmaceuticals Interest Group session on regulatory practices related to pharmaceuticals in the environment (PiE).
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.
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
- Study design and regulatory consultation
- PEC calculations
- Aquatic and terrestrial ecotoxicology, environmental fate
- Endocrine assessments - AMA, FSTRA, MEOGRT, FFLC, FSDT
- Authoring the Environmental Risk Assessment report
- Full US FDA coverage
- Study design and regulatory consultation
- Acute / chronic, aquatic / terrestrial ecotoxicology capabilities
- Risk Assessment or Categorical Exclusion reports