UK-First or EU-First? Strategic Sequencing for Sterile Injectable Market Entry
For US sterile injectable companies considering international expansion, the question is often framed too narrowly:
“Should we go into Europe?”
In practice, the more valuable question for senior management is:
“Where should we start — the UK, the EU, or neither — and why?”
Post-Brexit, UK and EU regulatory pathways have diverged just enough that sequencing decisions now carry meaningful regulatory, commercial, and operational consequences. Treating the UK as a simple proxy for Europe, or assuming that EU entry automatically subsumes the UK, can introduce avoidable risk.
A deliberate, evidence-based sequencing decision is therefore essential.
The UK and EU are no longer interchangeable entry points
While there remains substantial alignment between MHRA and EMA expectations, the two systems now operate independently. This affects:
Submission strategy and review timelines
Reference product availability and justification
Lifecycle management and post-approval variation planning
Manufacturing and supply chain flexibility
For sterile injectables — where margins are sensitive and execution risk is high — these differences matter.
The correct sequencing is rarely obvious without a structured review of the existing ANDA and the intended commercial model.
When a UK-first strategy can make sense
A UK-first approach may be appropriate when:
The ANDA data package aligns cleanly with MHRA expectations
Reference product and market access assumptions are clearer in the UK
A limited initial launch footprint is strategically desirable
Speed to first ex-US approval carries internal or investor value
In these cases, the UK can serve as a controlled environment to validate regulatory and operational assumptions before broader EU commitments are made.
However, UK-first should be a strategic choice, not a default.
When EU-first is the better option
An EU-first strategy may be preferable when:
The commercial opportunity is materially stronger across multiple EU markets
Manufacturing and supply are already structured for EU distribution
Regulatory strategy benefits from centralised EMA procedures
UK-specific requirements would add disproportionate complexity
In these scenarios, attempting to “test the water” in the UK can actually delay value creation rather than accelerate it.
The hidden risk: locking in the wrong sequence
One of the most common issues I encounter is not that a company chose the “wrong” region — but that it chose too early, without validating how the existing ANDA supports each pathway.
Once a filing strategy is set in motion, it tends to drive:
Manufacturing decisions
Tech transfer sequencing
Stability commitments
Resource allocation
Reversing course later is rarely cheap or quick.
This is why sequencing should be treated as a management decision, not a regulatory afterthought.
Sequencing should follow evidence, not convention
The most effective programmes I see begin with a structured assessment of the existing ANDA against both UK and EU expectations, alongside a clear-eyed view of commercial and operational constraints.
That process typically clarifies:
Whether one region genuinely de-risks the other
Where additional data or justification may be required
Which sequence best preserves optionality
In some cases, it also leads to the conclusion that neither pathway should be pursued immediately — a perfectly valid outcome when reached deliberately.
Conclusion
UK and EU market entry for sterile injectables is no longer a one-size-fits-all decision. The choice of where — and when — to file should be driven by evidence, not habit.
For senior management, the objective is not simply to enter a new market, but to do so in a way that aligns regulatory feasibility with commercial reality.
Sequencing decisions made early, with full visibility of their implications, are far more likely to create value than those made by default.