Capability
Global Registration
The same dossier filed through a different route can differ by a year and by a substantial margin in cost. Route selection is a strategic decision, and it is usually made by default.
Overview
The route decides more than the dossier
Teams entering Europe often start by asking what the dossier must contain. The more consequential question comes first: which route to use. That choice determines how many authorities assess the file, how questions are handled, how long approval takes and which territories the approval covers.
A centralised application yields one authorisation valid across the Union but commits you to a single assessment with no partial fallback. A decentralised procedure lets you choose the countries and gives you a reference member state, but you manage concerns from every concerned member state. Mutual recognition builds on an existing national approval. A national route is narrow but sometimes the fastest way into one specific market.
None of these is generally superior. The right route depends on how many countries you actually intend to launch in, how confident you are in the data package and how the timeline interacts with your commercial plan.
Route assessed against your territory list
Filing in five countries and filing in twenty-five are different problems. The recommendation follows your actual launch plan, not a template.
Gap analysis before the timeline
We establish what the chosen route requires and what you already have. Only then does a defensible schedule exist.
Supplier documentation mapped to the dossier
Where we also run the supply program, the manufacturer's documentation is verified against what the filing needs before submission.
Lifecycle planned from the start
Variations, renewals and post-approval commitments are foreseeable. Planning them at filing time avoids expensive rework later.
The routes
The four routes
These are the principal European options. Asia-Pacific, Middle East and Latin American frameworks are assessed on the same basis: coverage, control, timeline and fallback position.
Best for
Broad EU launch, or products where the procedure is mandatory
A single application assessed by the EMA yielding one marketing authorisation valid across the European Union. Mandatory for certain categories including most biotechnology-derived products and specified therapeutic areas.
What it means in practice
- One assessment, one authorisation, all member states at once
- Mandatory for defined product categories — check eligibility first
- A negative opinion applies everywhere; there is no partial fallback
- Highest evidentiary bar of the four routes
None of these routes is generally superior. Which one is right depends on your territory list, your data package and how the timeline interacts with your commercial plan.
In practice
How a registration program runs
The sequence is the same regardless of route; what changes is who assesses the file and how questions are resolved.
- 01
Territory & route assessment
Target countries, launch sequence and commercial timeline are mapped against the available routes, producing a recommendation with the trade-offs stated rather than a single assertion.
- 02
Dossier gap analysis
Existing documentation is compared against the requirements of the chosen route. Gaps are classified as reformatting, new data or new studies — which is what actually drives the timeline.
- 03
Dossier compilation
CTD modules are assembled, supplier-side documentation is verified against the filing, and internal consistency is checked before submission.
- 04
Submission & assessment
The application is filed through the agreed route. Questions and deficiency letters are answered against a tracked response plan with owners and deadlines.
- 05
Approval & lifecycle
On approval, variations, renewals and post-approval commitments are managed as scheduled obligations rather than reactive work.
Questions
Frequently asked
It depends on how many member states you will actually launch in, whether you already hold a national authorisation, how strong the data package is and how the approval timeline interacts with your commercial plan. The assessment in stage one exists precisely because there is no general answer.
Request a pathway assessment
Tell us the asset and the territories you are targeting. You will get the routes worth considering and what each would require of you.
Related
The other capabilities
How can we help you?
Receive insights into the latest events and regulatory updates
Sent directly to your email
Get industry insights and Unibest news here
Contact Us →