Environmental Risk Assessment (ERA) for Human Medicinal Products (acc. EMEA/CHMP/SWP/4447/00 Rev. 1-Corr.)

Experimental Studies for EMA-Compliant Environmental Risk Assessment

LAUS supports pharmaceutical companies with experimental studies for Environmental Risk Assessment (ERA) of human medicinal products in accordance with the latest European Medicines Agency (EMA) requirements.

Our laboratory is experienced with testing of all kinds of APIs (Active Pharmaceutical Ingredients) / AS (Active Substances) and is even authorised to handle controlled substances (narcotic drugs).

Environmental Risk Assessment According to EMA Guidelines

The current EMA Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) requires an ERA for all new marketing authorisation applications, including centralized, decentralized, mutual recognition and national procedures.

An update of the ERA is necessary in cases with an anticipated increase in environmental exposure (type II variations, new indications, line extensions…). LAUS provides the experimental data needed throughout the ERA process, helping pharmaceutical companies generate high-quality study results in accordance with current EMA and OECD requirements.

ERA Phase I

Phase I evaluates the potential environmental exposure of the active pharmaceutical ingredient (API).

The revised EMA guideline requires determination of the octanol/water partition coefficient (logKOW/logPOW) which may trigger a PBT/vPvB assessment (Log Kow ≥ 4,5).

If the calculated Predicted Environmental Concentration (PEC) exceeds the applicable trigger value, the medicinal product proceeds to Phase II Environmental Risk Assessment.

ERA Phase II Studies

Phase II assesses the environmental behaviour and ecotoxicological profile of the active substance. LAUS performs the core studies required under the EMA guideline and OECD test guidelines.

Our ERA Study Portfolio

Physico-chemical properties (4.2.1.1)

·      OECD 105 – Water Solubility

·      OECD 107 / OECD 123 – Partition Coefficient (n-octanol/water)

·      OECD 112 – Dissociation Constant (pKa)

·      OECD 101 – UV/VIS Absorption Spectrum (*)

·      OECD 102 – Melting Point / Melting Range (*)

·      OECD 104 – Vapour Pressure (*)

(*) Not mandatory

Fate properties (4.2.1.2)

·      OECD 106 – Adsorption/Desorption

·      OECD 301 – Ready Biodegradability

Aquatic toxicity (4.2.1.3)

·      OECD 201 – Algae 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 (4.2.1.3)

·      OECD 225 – Lumbriculus Sediment Toxicity Test

Antibacterials (4.3.1)

Active substances with a specific mode of action require a tailored testing strategy.

Studies for Antibacterial Substances:

·      OECD 201 – Synechococcus leopoliensis (Cyanobacteria)

·      OECD 201 – Raphidocelis subcapitata (Green algae)

·      OECD 201 – Anabaena flos-aquae (Cyanobacteria)**

**provided by a partner lab

Additional ERA Studies

Trigger values may require further assessment in Phase II Tier A:

·      Soil (4.2.6.1)

·      Groundwater (4.2.1.2)

·      Secondary poisoning (4.2.8)

Also, Refinements in the Phase II Tier B assessment may lead to the obligation of experimental in-depth investigation.

LAUS coordinates additional testing together with qualified partner laboratories. Let us know what you are looking for.

Why Choose LAUS?

·      Experimental ERA studies according to current EMA requirements

·      OECD guideline-compliant testing

·      GLP expertise

·      Licensed to handle controlled substances (narcotic drugs)

·      One partner for physicochemical, fate and ecotoxicological studies

·      Support throughout the entire ERA study program

·      Network of toxicologists

·      Network for regulatory work

·      Network of qualified partner laboratories for complementary studies

Contact Our ERA Experts

Planning an Environmental Risk Assessment for a human medicinal product?

Our scientists are happy to discuss your project and recommend the appropriate experimental study program.

We also have experienced specialists in our network to assist you with toxicological and regulatory work.