Strengthening regulatory consistency - why predictability matters rather more than speed

In many ways, science is moving faster than the regulatory system around it. For Europe, its complexity in this area becomes particularly apparent when bringing innovative medicines to the clinic, especially when products span multiple regulatory frameworks, such as those involving medical devices or in vitro diagnostics.

Gene therapies provide just one example of this challenge:

• · The product itself requires authorisation as an investigational medicinal product under the Clinical Trials Regulation¹
• · Where the study relies on a diagnostic to select or monitor patients, a separate performance study application is needed under the In Vitro Diagnostic Regulation²
• · These therapies use a genetically modified virus, so clearance is also required under national GMO frameworks.

This snapshot of three of the applicable regulations means three separate processes and three sets of reviewers. None of these processes were designed to run alongside one another, and they vary by country. Legal and practical interpretation varies as well and not only between EU Member States.

At Regeneron, in our experience across serious diseases, regulatory processes can even vary between institutions within the same country. It is possible to hold a positive decision on the medicinal product and still be waiting several months on a GMO approval, with sites ready and patients waiting to get started.

It is a rather different picture internationally. In the US and Canada, clinical trial application timelines typically run to one or two months, and Canada does not require a separate in vitro diagnostic device submission at all.^3,4 This means Europe can often lag behind.

What this means for development teams

The decision about where to hold a clinical study is rarely a judgement about the quality of European science. We have excellent research sites across Europe, with committed investigators. The question senior teams find themselves asking is simpler: how confident can we be in the start-up date based on the various approvals needed?

In a global development programme, the first patient in one region tends to set the pace for everything behind it - data cuts, interim analyses, filing dates and launch readiness all sit downstream of that single milestone.

Predictability is worth more than speed”

Where a region cannot be predicted with much confidence, it will tend to attract fewer studies or receive them later. Which is why we would suggest that predictability is worth more than speed. A twelve-week process that can be planned around is generally more useful than an eight-week process that occasionally takes twenty-six. It is the variance that causes difficulty, not the average.

What we have learned

A few things have changed in how we approach European studies.

The first is straightforward. We now work on the assumption that the slowest of the three approvals will set the timeline, building the country strategy around that rather than around the medicinal product application alone.

Country selection needs to account for the full set of approvals, not simply the one that sits in the Clinical Trial Information System (CTIS).

The second is that early and open engagement with national authorities and ethics committees is time well spent, particularly where a technology is new to a given country. A significant amount of the challenge we encounter is not disagreement about the science. More often it reflects unfamiliarity, or a different understanding of the same requirement.

The third is perhaps most challenging. We have had to build and maintain a fair amount of institutional knowledge about how individual countries and committees tend to behave, because the written rules do not tell you quite enough on their own.

The difficulty in Europe, is no longer an absence of common rules so much as the inconsistent application of the rules we already have.

Where the improvement can be found

Three changes would make a meaningful difference.

• · Simplify the interface between the regulations, ideally through a single CTIS-type platform that sponsors find genuinely workable
• · Align timelines across those regulations so that the clocks run together
• · Greater consistently of interpretation, including at ethics committee level.

The Biotech Act offers a helpful illustration of what that might look like in practice. It proposes a single application pathway for combined studies that pair a medicinal product with a medical device or an in vitro diagnostic.⁵ The sponsor submits once, a coordinated assessment follows and the duplicated procedures fall away. The instinct behind it seems the right one, though whether it delivers will depend on how Member States choose to apply it.

The continued emphasis by the EMA to streamline and shorten regulatory pathways and reduce unnecessary procedural steps points in a similar direction. Europe does not need to compete on speed alone, it must become somewhere sponsors can reasonably predict what will happen and when.

References

1. Clinical Trials. [Internet] European Commission [Cited 2026 Aug]. Available from: https://health.ec.europa.eu/medicinal-products/clinical-trials_en
2. The COMBINE Programme. [Internet] European Commission [Cited 2026 Aug]. Available from: https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme_en
3. Investigational New Drug (IND) Application. [Internet] US Food and Drug Administration (FDA). [Cited 2026 Aug]. Available from: https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
4. IND Application Procedures: Clinical Hold. [Internet]. US Food and Drug Administration (FDA). [Cited 2026 Aug]. Available from: https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold
5. Thacker Z, Hines P, Bamford C, Bergström R. The EU’s Biotech Act (Part 2): Compelling Changes to Clinical Trial Regulation. [Internet]. IQVIA. 2026. [Cited 2026 Aug]. Available from: https://www.iqvia.com/locations/emea/blogs/2026/06/the-eu-biotech-act-part-2