The environment has become a regulatory obligation for pharmaceutical companies on two fronts at once. On one side sits the marketing authorisation dossier, where the European Medicines Agency’s revised environmental risk assessment guideline has raised expectations for what applicants must submit. On the other sits the recast Urban Wastewater Treatment Directive, which turns environmental impact into a direct financial liability. Companies that treat these as separate problems — one for regulatory affairs, one for finance — are likely to be caught out by both.
The revised ERA guideline: what changed
The EMA issued Revision 1 of its guideline on the environmental risk assessment (ERA) of medicinal products for human use in February 2024, and it has applied since 1 September 2024. It replaces guidance that had been in place since 2006 — a long interval in a field where the underlying environmental science has moved considerably.
An ERA is required for every new marketing authorisation application for a human medicine, whether the route is centralised, mutual recognition, decentralised or purely national. The assessment itself remains structured in phases:
- Phase I estimates the predicted environmental concentration (PEC) in surface water. A PEC at or above 0.01 µg/L triggers the next phase.
- Phase II covers fate and effects testing, and where necessary a more refined assessment of risk to the aquatic and terrestrial compartments.
- Certain substance classes — endocrine-active substances, antibacterials and antiparasitics — proceed to Phase II irrespective of the calculated PEC, on the basis that the standard exposure trigger does not adequately capture their hazard profile.
Where ERA submissions run into trouble
In practice, most ERA deficiencies are not scientific failures but planning failures. Recurring themes include:
- Starting too late. Phase II ecotoxicity and degradation studies take months and must be conducted to a recognised standard. An ERA cannot be assembled in the weeks before submission.
- Assuming a generic or hybrid application needs less. The revised guideline narrows the circumstances in which an applicant can justify the absence of a full ERA for an already-authorised substance where the original assessment is not available to them.
- Forgetting the lifecycle. A type II variation or a new indication that could meaningfully increase environmental exposure calls for an updated ERA — a point easily missed in a portfolio of routine changes.
- Weak documentation of the PEC calculation. Assessors want to see the assumptions, the market penetration figures used and the justification for each, not simply the final number.
The wastewater directive: from dossier to balance sheet
Directive (EU) 2024/3019, the recast Urban Wastewater Treatment Directive, entered into force on 1 January 2025 and replaces the 1991 directive. Alongside stricter treatment standards, it introduces quaternary treatment for the removal of micropollutants — and an extended producer responsibility (EPR) scheme to pay for it.
Under that scheme, producers placing products listed in Annex III on the market must cover at least 80% of the costs of quaternary treatment, including investment, operating and monitoring costs. Member States may require producers to cover up to 100%. Pharmaceutical products fall squarely within scope, and the EPR obligations apply from the end of 2028.
The provisions remain contested. Actions brought by pharmaceutical and cosmetics companies were dismissed by the General Court in February 2026 on admissibility grounds, an appeal to the Court of Justice followed, and the Irish High Court has referred questions on the interpretation of the EPR provisions for a preliminary ruling. The direction of travel, however, is clear enough that waiting for final judgments is not a strategy. National transposition is under way, and the cost base will be set by how each Member State implements Annex III and allocates contributions.
How PQRA helps
PQRA supports pharmaceutical companies and healthcare innovators across the full environmental compliance picture. We plan and compile ERAs for new marketing authorisation applications, review existing dossiers against the revised guideline, and identify which variations in a portfolio trigger an ERA update. We also help companies assess their exposure under the extended producer responsibility scheme as it is transposed in Greece and elsewhere in the EU, so that the commercial implications are understood well before the obligations bite.
Environmental compliance now sits at the intersection of regulatory affairs, quality and commercial strategy. Get in touch with PQRA to discuss how these requirements affect your products and your submission plans.
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