| Author: Alison Kneen, Global Market Access Practice Lead, BioVid

The timeline between clinical development and commercial launch is shrinking.

Not because science is moving faster, but because regulators, HTA bodies, and market access expectations are becoming increasingly interconnected.

The European Medicines Agency’s (EMA) new phased review process is the latest example of this shift. While much of the attention has focused on the potential for faster regulatory review, the more important implication is what it means for how pharmaceutical companies plan evidence generation, market access, and launch readiness.

For organizations still treating these activities as sequential milestones, the pace of change may become the greatest challenge.

What Is Changing?

On July 7, 2026, daraxonrasib became the first therapy to enter EMA’s new phased review process.

Similar to the FDA’s rolling review approach, phased review allows the Committee for Medicinal Products for Human Use (CHMP) to begin evaluating sections of a Marketing Authorization Application (MAA) as they become available, rather than waiting for a complete submission package.

The goal is straightforward: accelerate access to innovative medicines by shortening the overall regulatory review process.

Daraxonrasib was selected because of its potential to address a significant unmet medical need in metastatic pancreatic cancer, where patients currently face limited treatment options and poor outcomes. The therapy also received orphan medicinal product designation and was prioritized under the EMA’s Cancer Medicines Pathfinder initiative.

While this serves as an important regulatory pilot, its significance extends well beyond a single product.

The Bigger Story

Viewed alongside the implementation of EU Joint Clinical Assessments (JCAs), phased review represents another step toward a more integrated European market access environment.

Historically, clinical development, regulatory submission, HTA preparation, pricing, reimbursement, and commercialization often followed a largely sequential path.

That model is changing.

Increasingly, regulators and HTA bodies expect evidence to be available earlier, decisions to be made sooner, and cross-functional teams to work in parallel rather than in sequence.

The organizations that adapt to this compressed planning environment will be better positioned to capitalize on accelerated pathways and reduce downstream launch risk.

Strategic Implications for Pharmaceutical Companies

Evidence Strategy Must Move Earlier

• Evidence generation can no longer be viewed as something finalized immediately before submission.
• Clinical, HEOR, and market access teams should be aligned much earlier to ensure evidence packages satisfy both regulatory and HTA requirements, reducing the need for costly revisions later in the process.

Launch Planning Becomes a Parallel Activity

• As regulatory timelines shorten, the window between submission and commercialization narrows.
• Pricing, reimbursement, medical affairs, commercial planning, and market access activities should begin earlier to ensure launch readiness keeps pace with regulatory progress.

Evidence Gap Analyses (EGAs) Become Increasingly Critical

• Earlier EGAs help identify potential weaknesses before submissions are underway.
• Understanding where additional data, endpoints, or economic evidence may be required gives organizations more flexibility to address gaps proactively rather than reactively.

Comparator Strategy Can No Longer Wait

• Comparator selection and Indirect Treatment Comparison (ITC) strategies have always been important.
• Under accelerated pathways, they become critical earlier in development, influencing both regulatory review and downstream reimbursement discussions.

Questions Leadership Teams Should Be Asking

The introduction of phased reviews raises important strategic questions:

• Are our Regulatory, HEOR, Market Access, and Commercial teams planning as an integrated organization?
• Does our evidence generation strategy satisfy both regulatory and HTA expectations from the outset?
• Are comparator strategies being established early enough to support reimbursement success?
• Which assets within our pipeline could benefit most from accelerated regulatory pathways?
• Does our launch planning process reflect today’s regulatory environment—or yesterday’s?

Looking Ahead

Phased review is unlikely to be the final evolution in the EU’s regulatory landscape.

Together with JCAs and broader reforms across the EU, it reflects a clear direction of travel: regulatory review, evidence generation, HTA, and commercialization are becoming increasingly interconnected.

Organizations that view phased review simply as a faster regulatory process may achieve incremental efficiencies.

Those that recognize it as a catalyst for earlier planning, stronger cross-functional alignment, and integrated launch strategies will be better positioned to accelerate patient access while strengthening launch success.