Environmental Risk Assessment for Generics: Necessary Safeguard or Costly Box-Ticking?

Environmental Risk Assessment (ERA) has long been part of pharmaceutical regulation. But recent changes are raising an uncomfortable question:

Are we improving environmental protection… or just increasing cost and complexity?

At SETAC EU 2026, Martin Bowyer and colleagues from Blue Frog Scientific explore this challenge in a thought-provoking poster presentation.

Poster Presentation

“Environmental Risk Assessment of Generic Human Pharmaceuticals”
Presentation ID: 3.21.P-Tu372
Blue Frog Scientific – Booth 79

What Regulation has Changed?

Under Directive 2001/83/EC, all new marketing authorisations must include an Environmental Risk Assessment (ERA).

Historically, generic products could often rely on a simple justification: no increase in environmental exposure = no additional risk. But as highlighted on the poster, updated EMA guidance (September 2024) has removed this option

Generics may now require full environmental risk assessments, even where the originator product has been on the market for years.

The Real-World Challenge

The updated framework introduces a series of practical hurdles:

1. Existing ERA? Not so simple.

• Many pre-2006 substances have no ERA at all.
• Public data (EPARs) is inconsistent or incomplete.
• Confirming status can require formal data access requests.
   

2. Data Sharing Barriers

Even where an ERA exists:

• Data access is rarely granted.
• No legal incentive for originators to share.
• EPAR summaries cannot replace underlying data.

This creates a paradox:

A scientifically valid ERA may exist…
But cannot be used.

3. Starting Again Comes at a Cost

Without access to original data:

• Full ERA testing may be required
• Typical costs: £250,000–£300,000+
• Includes vertebrate studies (e.g. OECD 210, 305)

And in many cases, this duplicates work that has effectively already been done.

Does It Change the Outcome?

Here’s the most striking insight from the poster:

“The outcome of the ERA should not constitute a criterion for refusal of a marketing authorisation.”

In practice:

• ERA has minimal impact on approval decisions.
• Risk mitigation often results in:
  • Standard disposal instructions.
  • Minor SmPC updates.

Which raises a difficult question:

Are these measures meaningfully reducing environmental risk?

Key Takeaways

• The 2024 guideline update removes previous flexibility for generics.
• Data-sharing limitations create inefficiency and duplication.
• Costs may make some generic products financially unviable.
• Increased testing may lead to more animal studies without clear benefit.
• The overall environmental impact of these changes is uncertain.
   

Not Just a Compliance Issue

If you work in; pharmaceuticals (especially generics), regulatory affairs, environmental risk assessment, product strategy or lifecycle management, we hope this poster presentation will be of interest.

This is not just a compliance issue – it’s a commercial and ethical one. This poster is likely to spark debate, and Blue Frog Scientific would love to hear your perspective.

Visit us at Booth 79 to speak with our team of expert regulatory consultants and explore practical strategies for navigating ERA under the new framework.

Download a copy of Martin's poster here...