EU Pharma Reform 2026–2028: What It Means for Environmental Risk Assessment
The European Parliament and the Council of the European Union reached political agreement on the reform of the EU pharmaceutical legislation on 11 December 2025.
Following final legal‑linguistic checks, the adopted acts of the new pharmaceutical legislation are expected to be formally adopted and published in the Official Journal in 2026. Once published, the legislation will enter into force 20 days later.1
A transition period of two years will then apply, running until 2028. During this time, all EU Member States must update their national laws to align with the new framework.
In parallel, the European Commission, EMA and Member States will develop and publish implementation guidance to support stakeholders.
This reform represents the most significant overhaul of the EU pharmaceutical regulatory framework in more than two decades. It will modernise how medicines are developed, authorised and made available to patients across the EU. Importantly, the revised legislation is also expected to strengthen environmental obligations for pharmaceutical companies.
Under the new framework, environmental risk assessment (ERA) is no longer treated as a one‑off requirement at the point of marketing authorisation. Regulators are moving toward a lifecycle‑based approach, considering manufacturing, use, disposal, environmental exposure, monitoring and ongoing risk management throughout a product’s lifespan.
The ERA 2024 Guideline will remain the basis for evaluating environmental risk assessments. However, the new legislation introduces significant challenges for existing and generic products.
Historically, many products authorised before 2005 entered the market with little or no formal ERA, often relying only on general environmental statements. Under the revised framework, this position is changing substantially.
Regulators are expected to establish prioritisation programmes to identify substances requiring updated or newly generated environmental assessments. These programmes are likely to focus on active substances with:
• high environmental exposure potential
• ecological concern
• data gaps or outdated assessments
This creates a substantial challenge for generic manufacturers and MAHs responsible for long‑established products.
Many companies may find that:
• No ERA exists for their active substance
• Existing ERA documentation is incomplete
• Historical assessments do not meet current guideline expectations
• Existing data are unavailable due to ownership or access restrictions
As a result, consortia, cost‑sharing and data‑sharing mechanisms will become increasingly important — particularly for small and medium‑sized companies.
Contact Sharon Swales, Managing Director (ERS Europe) to discover how Smithers ERS can support your ERA needs.
1 Visit https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en to find out more