Engaging Early with EMA Scientific Advice: A Strategic Advantage for Sponsors

For companies planning clinical trials or pursuing marketing authorization in the European Union (EU), early engagement with the European Medicines Agency (EMA) through its Scientific Advice procedure can be a game-changing strategy. This is especially true for small to mid-sized developers and non-EU sponsors who may be less familiar with the European regulatory environment.

Understanding EMA Scientific Advice

EMA Scientific Advice is a confidential, non-binding consultation service that provides tailored feedback on development strategies for medicines. It is available to pharmaceutical and biotech companies, academic institutions, and other developers at any stage of development — though its value is maximized when sought early.

This process allows developers to align their plans with EU regulatory expectations and make evidence-based decisions on clinical trial design, preclinical requirements, manufacturing, and other critical areas. The advice is delivered in writing, usually within a few months, following submission of a detailed briefing dossier and a meeting (often virtual) with the Scientific Advice Working Party (SAWP).

What the Process Offers

Key features of EMA Scientific Advice include:

• Confidentiality: Discussions remain private, allowing sponsors to share development strategies without public disclosure.
• Customization: Advice is tailored to the specifics of the product and development plan.
• Non-binding Guidance: While not mandatory, the feedback represents regulatory expectations and is typically followed to avoid issues later in the review process.
• Repeat Access: Sponsors can request advice at multiple stages — before initiating Phase 2 or 3 trials, or ahead of marketing submissions.
• Incentives for SMEs and Orphan Products: Small and medium-sized enterprises (SMEs) can qualify for fee reductions, and products with orphan designation are eligible for free advice.

Why Early Engagement Matters

Engaging early with EMA Scientific Advice delivers multiple benefits that can significantly improve development outcomes:

1. Optimized Study Design
   EMA can provide feedback on study endpoints, patient populations, and statistical approaches, helping developers design trials that are scientifically sound and regulatorily aligned.
2. Fewer Regulatory Surprises
   By addressing potential objections upfront, sponsors reduce the risk of major issues during marketing authorization review, streamlining the path to approval.
3. Efficient Resource Allocation
   EMA may confirm that certain studies or data are unnecessary, helping companies focus on high-priority activities and avoid avoidable delays and costs.
4. Greater Regulatory Clarity
   Scientific Advice helps demystify the EU regulatory landscape and may open doors to expedited pathways like PRIME for products addressing unmet medical needs.
5. Higher Submission Quality
   Although EMA does not publish specific success metrics, early regulatory engagement is widely associated with stronger submissions and a smoother review process.

Actionable Steps for Developers

To make the most of EMA Scientific Advice, consider the following strategies:

• Plan Ahead: Incorporate scientific advice into your development timeline — ideally before starting pivotal trials — to allow time for any needed adjustments.
• Use the IRIS Platform: Submit applications through EMA’s IRIS system, which centralizes the process and offers structured guidance.
• Take a Collaborative Approach: Be transparent in your briefing document about uncertainties or alternative strategies. This invites more targeted and constructive feedback.
• Leverage SME Status: If eligible, apply for SME designation early to benefit from financial and procedural support.

Preparing a Strong Submission

A well-prepared Scientific Advice package improves the quality of feedback you receive. Typical documentation includes:

• A cover letter summarizing the request
• A detailed briefing document with product background, clinical plans, regulatory context, and clearly worded questions
• A draft clinical trial protocol (for clinical advice)
• Preclinical and CMC summaries, if applicable
• The latest Investigator’s Brochure (IB)
• A target product profile (TPP) or development roadmap, if available

For advanced therapy products (ATMPs), ensure additional quality and manufacturing data is included. All materials should be submitted at least 70 days before the anticipated discussion using EMA templates and the IRIS portal.

Your Partner in Regulatory Success

At Cromos Pharma, we specialize in helping sponsors navigate the complexities of EMA Scientific Advice. Our team of regulatory experts supports every step of the process — from preparing briefing packages to coordinating submissions and integrating feedback into development plans. Whether you’re initiating your first EU trial or expanding a complex portfolio, our end-to-end support ensures your program is aligned with regulatory expectations and built for success.

Contact us today at inquiry@cromospharma.com to explore how Cromos Pharma can support your EMA engagement strategy.