Environmental Risk Assessment (ERA)
ERA assesses environmental risks posed by pharmaceutical products. It minimizes drug impact, identifies risk measures, and ensures proper disposal. CEHTRA provides expert guidance and independent study monitoring for compliance.
Senior Ecotoxicologist, ERA
Head of Pharmaceuticals
EU's Proposal to Strengthen Environmental Risk Assessment (ERA) for Pharmaceutical Products
In the EU, an Environmental Risk Assessment (ERA) has been required since 2006 (CPMP/SWP/4447/00, 20061) for any new application for marketing authorization (MA) for a drug, or when there is a potential for a significant increase in environmental concentrations following changes in use of existing MAs (e.g. addition of new indications). Drugs authorized before this date do not currently require an ERA.
To achieve the environmental sustainability ambitions of the European Green Deal, the pharmaceutical industry will have to limit the negative impact of its products (and processes) on the environment, biodiversity and human health. Scientific evidence shows that pharmaceutical products are present in the environment as a result of their manufacture, use by patients and inappropriate disposal.
The proposal to reform pharmaceutical legislation (Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC) meets a number of commitments on the strategic approach to pharmaceuticals in the environment. It strengthens the ERAof medicinal products to ensure better evaluation and limit the potential negative impacts of medicinal products on the environment and public health.
In summary, the EU wishes to strengthen ERA for the marketing of pharmaceutical products by :
Strengthening the ERA, by introducing a ground for refusal of marketing authorization when companies fail to provide sufficient evidence for ERA, or if the proposed risk mitigation measures are not sufficient to address the risks.
Establish clearer requirements for ERA, including compliance with scientific guidelines, regular ERA updates and post-authorization obligation for additional ERA studies.
Extend the scope of ERA to environmental risks arising from antibiotic manufacturing.
Extend ERA to all products already on the market and potentially harmful to the environment.
(COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS, Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance, 26.4.2023)
The aim of an ERA for pharmaceutical products is to :
minimize the amount of drug released into the environment through appropriate measures.
identify specific risk minimization measures to be undertaken by users.
appropriate labeling, to facilitate proper disposal of the drug by patients/healthcare professionals (e.g. ensuring that drugs are disposed of in special containers or returned to pharmacies).
The ERA is divided into 3 phases:
Phase I: aims to identify the total environmental exposure of pharmaceutical products based on dosage and prevalence of the targeted pathology, and to study their potential for bioaccumulation and persistence in the environment.
If specific risks are identified (estimated concentration in the environment greater than 0.01 µg/L, PBT substance or substance of concern), further assessment and a number of studies must be carried out (Phase IIA).
Phase IIA: Phase II tests identify the fate of drugs in the environment and their potential effects on representative aquatic and terrestrial organisms, in order to assess whether the risk is acceptable.
Phase IIB: If the risk is not considered acceptable, a refined assessment must be carried out (additional studies, modeling of environmental concentrations, risk management measures to be implemented).
At CEHTRA, our ecotoxicologists can help you to prepare your ERA dossiers and monitor the studies required
We have completed dozens of ERA dossiers in accordance with current guidelines.
We are 100% independent of CROs, so we help our customers to carry out only the essential tests.
The monitoring of studies by our consultants also ensures that our study reports are as robust as possible.