The European Medicines Agency (EMA) requires that an Environmental Risk Assessment (ERA) accompany every Marketing Authorization Application (MAA) for a new pharmaceutical. Likewise, the US Federal Drug Administration (FDA) stipulates that a Risk Assessment or Categorical Exclusion claim accompanies every Investigational New Drug (IND), New Drug Application (NDA), or Biologics License Application (BLA).

Smithers has supported the EU and US submission of over 250 drugs by providing expert regulatory and testing services for environmental risk assessments from our UK and US laboratories.

Recently, the EMA issued a new Guideline for the Environmental Risk Assessment of pharmaceuticals that expands the scope of testing.

Key changes to the prior guideline include the introduction of the specific assessment for Endocrine Disrupting Substances (ED), Antimicrobials (AM), and Antiparasitics (AP), and a strengthening of the Persistent Bioaccumulative Toxic (PBT) assessment.

A summary workflow and decision tree is available for download.

Smithers is fully versed in these regulatory changes and can advise on the optimal path to navigate these new requirements – contact us today for your consultation.

Full and Partial Package Support for EMA Environmental Risk Assessments
  • 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
    • Predicted Environmental Concentration (PEC) calculations
    • ED, AM, AP and PBT assessments
      • Endocrine testing - Fish Short-term Reproductive Assay, (FSTRA), Amphibian Metamorphosis (AMA), Larval Amphibian Growth and Development Assay (LAGDA), Fish Sexual Development Testing (FSDT), Medaka Extended One-Generation test (MEOGRT) and Fish Full-Life Cycle (FFLC) tests, including Extended One-Generation test with Fathead Minnow (FEOGRT), and more
    • Aquatic and terrestrial ecotoxicology, environmental fate
    • Groundwater, soil, and secondary poisoning evaluations
    • Authoring the Environmental Risk Assessment report  
Full US FDA coverage
  • Study design and regulatory consultation
  • Acute / chronic, aquatic / terrestrial ecotoxicology capabilities
  • Authoring the Risk Assessment or Categorical Exclusion reports

Download the summary workflow and decision tree:

Smithers 2024 Update to Environmental Risk Assessment
Show Policy
Show Policy

Download staff poster publications:

Challenges in the one-size fits all approach to the Environmental Risk Assessment of pharmaceuticals
A Consistent Approach for PBT/vPvB Assessment for Pharmaceutical Products
Environmental Fate of Estetrol (E4) a native estrogen in oral contraception

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