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Environmental Risk Assessment ERA

Environmental Risk Assessment ERA (acc. EMEA/CHMP/SWP/4447/00 Rev. 1):

LAUS supports you in conducting the Environmental Risk Assessment (ERA) for the approval of your Human Medicinal Products according to the requirements of the European Medicines Agency (EMA). The dossier for a marketing authorization for medicinal products for human use (HMP) must include an Environmental Risk Assessment (ERA). The ERA is based on the intended use of the product, the ecotoxicological and physico-chemical properties as well as the environmental fate of the active substance of the product.

Risk assessment, Phase I:

Draft Guideline EMEA/CHMP/SWP/4447/00 Rev. 1. states that in Phase I the potential for environmental exposure of the active substance of the medicinal product needs to be analyzed and evaluated. The risk assessment according to Phase I consists of a decision tree (for details refer to the homepage of the European Medicines Agency (EMA)).

Risk assessment, Phase II:

Phase II risk assessment is based on the physico-chemical properties, environmental fate and toxicity of active substances. With help of these parameters important information about the drug in the environment can be obtained. In this context, we at LAUS GmbH carry out studies according to Phase II of ERA, which examine the physico-chemical properties, as well as the environmental fate and the ecotoxicity of the drug and enable an evaluation (EMEA/CHMP/SWP/4447/00 Rev. 1.).

Table 1: Mandatory and non-mandatory studies according to Phase II of ERA:

  • Physico-chemical properties (4.2.1.1)
    OECD 105 Water Solubilty
    OECD 107 or 123 Partition Coefficient (n-octanol/water) (#)
    OECD 112 Dissociation Constants in Water
    OECD 101 UV-VIS Absorption Spectra (*)
    OECD 102 Melting Point/Melting Range (*)
    OECD 104 Vapour Pressure (*)
  • Fate properties (4.2.1.2)
    OECD 106 Adsorption/Desorption using a Batch Equilibrium Method with 3 soils and 2 sludges
    OECD 301 Ready Biodegradability Test
  • Aquatic toxicity (4.2.1.3)
    OECD201 Freshwater Algae and Cyanobacteria, Growth Inhibition Test
    OECD 211 Daphnia magna Reproduction Test
    OECD 210 Fish, Early-life Stage Toxicity Test (Danio rerio)
  • Functioning of STP (4.2.5.1)
    OECD 209 Activated Sludge, Respiration Inhibition Test
  • Sediment toxicity (choose one of the tests below) (4.2.1.3)
    OECD 225 Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment
    OECD 218/219 Sediment-Water Chironomid Toxicity Using Spiked Sediment/Spiked Water
    OECD 233 Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment

(*) Not mandatory

(#) Study also required for Phase I PBT screening.