PVpharm is pleased to announce the expansion of its regulatory and scientific services to include Environmental Risk Assessments (ERA) for medicinal products. This new service strengthens our commitment to sustainable and responsible pharmaceutical development, supporting our clients in meeting European and international regulatory requirements.
Legislation and Context
In the European Union, conducting an ERA is mandatory component of all marketing authorisation applications (MAAs) for medicinal products for human use, as required by Directive 2001/83/EC and Regulation (EU) 2019/6. ERA reports must be submitted in Module 1.6.1 of the Common Technical Document (CTD) and apply to centralised, decentralised, mutual recognition, and national procedures. Any post-authorisation variations that could increase environmental exposure, such as new indications, expanded patient populations or formulations, also require an updated ERA.
In the United States, similar obligations exist under the National Environmental Policy Act (NEPA) and FDA environmental regulations.
Obligation
ERAs are required at the time of submission of a marketing authorisation and must be updated after authorisation if new information changes the environmental profile of the product. While ERA outcomes do not generally constitute a reason for marketing authorisation refusal, the process ensures transparency, regulatory compliance, and alignment with sustainability expectations.
ERA Methodology
ERAs are conducted in two main phases, following EMA guidance and ICH recommendations:
- Phase I – Initial Assessment / Screening
In this first step, the Predicted Environmental Concentration (PEC) in surface waters is calculated.- If PEC < 0.01 µg/L, Phase II is not required.
- If PEC exceeds the threshold or the drug has concerning properties (PBT, AMR, hormonal activity, etc.), Phase II is performed.
- Phase II – Detailed Assessment
This phase is divided into two parts:- Phase II A: Environmental Fate: Includes degradation (photolysis, biodegradation, hydrolysis), adsorption/desorption in sediments and soils, and relevant metabolites.
- Phase II B: Ecotoxicological Effects: Includes toxicity testing in algae, Daphnia, and fish, assessment of chronic and soil toxicity when relevant.
The Predicted No Effect Concentration (PNEC) is then determined and compared with PEC:
- PEC/PNEC < 1 → Risk considered acceptable
- PEC/PNEC > 1 → Additional studies or risk mitigation measures required
These assessments allow the inclusion of specific environmental safety messages in the SmPC and patient leaflet, such as:
“Do not dispose of medicines via wastewater or household waste.”
PVpharm Services
PVpharm is now able to provide comprehensive support for ERA processes, including:
- Regulatory advice on environmental compliance
- Compilation and review of technical data
- Preparation of ERA dossiers (Module 1.6.1 of the CTD)
- Coordination with laboratories and CROs
- Management and follow-up of post-authorisation ERA updates
With extensive experience across EU and non-EU markets, our team ensures that ERA submissions are scientifically robust, fully compliant, and aligned with EMA and national authority expectations. This approach supports harmonised global regulatory strategies while contributing to corporate sustainability goals.
By integrating environmental risk management early in the product lifecycle, companies can streamline regulatory pathways, anticipate data requirement, and demonstrate leadership in sustainable and responsible innovation.
The introduction of ERA services represents a strategic enhancement of PVpharm’s mission to deliver high-quality regulatory and pharmacovigilance solutions. Through these capabilities, we support our clients in meeting scientific, regulatory, and ethical standards while contributing to the protection of patients, public health, and the environment.
