EMA Scientific Advice: Your Complete Guide to European Regulatory Guidance

EMA scientific advice is a formal procedure through which the European Medicines Agency provides recommendations to pharmaceutical and biotech sponsors on the development and evaluation of medicinal products. This guidance helps companies design clinical trials, select appropriate endpoints, and align their development strategy with European regulatory expectations before submitting a marketing authorization application.

Getting early regulatory input can mean the difference between a streamlined approval process and costly protocol amendments that delay your product by years. For companies targeting the European market, EMA scientific advice represents one of the most valuable tools available to reduce development risk.

In this guide, you will learn:

• How the EMA scientific advice procedure works from request to final advice letter
• The complete fee structure including reductions for SMEs and orphan drug developers
• Key differences between scientific advice and Protocol Assistance for orphan products
• How EMA advice compares to FDA Type B meetings for global development planning
• Step-by-step instructions for preparing and submitting your scientific advice request

What Is EMA Scientific Advice?

EMA scientific advice is a formal consultation process administered by the European Medicines Agency to help medicine developers optimize their development programs for European approval. The advice covers quality, non-clinical, and clinical aspects of drug development, including study design, endpoints, comparators, and statistical approaches.

Key characteristics of EMA scientific advice:

• Provided by the Scientific Advice Working Party (SAWP) on behalf of the Committee for Medicinal Products for Human Use (CHMP)
• Available at any stage of development from early preclinical through post-marketing
• Covers all product types including small molecules, biologics, ATMPs, and biosimilars
• Addresses specific questions submitted by the sponsor rather than general guidance

The European Medicines Agency advice process is designed to be collaborative. Unlike a simple question-and-answer exchange, it involves detailed review of your development plan, often including face-to-face or virtual meetings with scientific assessors from EU national competent authorities.

Types of EMA Scientific Advice

The EMA offers several categories of regulatory advice depending on your product type and development situation. Understanding these options helps you select the most appropriate pathway for your program.

Standard Scientific Advice

Standard EMA scientific advice is available for any medicinal product seeking marketing authorization through the centralized procedure. This includes:

• New chemical entities and new biological entities
• Biosimilars and generic medicines
• Fixed-dose combinations
• New indications for approved products
• Pediatric development programs

Protocol Assistance for Orphan Drugs

EMA Protocol Assistance is a specialized form of scientific advice available exclusively for designated orphan medicinal products. Protocol Assistance offers significant fee reductions and is specifically designed to help sponsors meet the requirements for orphan drug approval in Europe.

Protocol Assistance is particularly valuable because orphan drug development often involves small patient populations, novel endpoints, and limited natural history data. EMA Protocol Assistance helps sponsors design feasible studies that will satisfy regulatory requirements despite these challenges.

Parallel Scientific Advice (EMA-FDA)

For companies developing products for both US and European markets, EMA and FDA offer parallel scientific advice through a collaborative procedure. This allows sponsors to receive coordinated feedback from both agencies simultaneously.

Benefits of parallel advice:

• Single briefing document addresses both agencies
• Coordinated meeting with EMA and FDA representatives
• Aligned feedback reduces conflicting development requirements
• Faster global development timelines
• Cost savings compared to sequential national procedures

Qualification Advice

EMA also offers qualification advice for novel methodologies, biomarkers, or clinical trial designs that are not yet established regulatory standards. Qualification advice can support:

• Drug development tools and biomarkers
• Clinical outcome assessments
• Model-informed drug development approaches
• Innovative clinical trial designs

The Scientific Advice Procedure Step by Step

Understanding the EMA scientific advice procedure helps you prepare effectively and set realistic timelines for your development program.

Step 1: Letter of Intent (Day -70 to -60)

Before submitting your formal request, you must notify EMA of your intention to seek scientific advice. The Letter of Intent includes:

• Product name and active substance
• Proposed therapeutic indication
• Brief development status overview
• Scope of advice requested (quality, non-clinical, clinical)
• Preferred timing for the advice

Submit the Letter of Intent at least 60 days before your target SAWP meeting date.

Step 2: Pre-submission Meeting (Optional)

EMA offers optional pre-submission meetings to discuss procedural aspects and clarify the scope of your request. This meeting is particularly useful if:

• Your questions span multiple development areas
• You are requesting advice on novel or complex topics
• You want to confirm your briefing document structure
• You need guidance on fee reduction eligibility

Step 3: Briefing Document Submission (Day 0)

The briefing document is the core of your scientific advice request. It must include:

The briefing document must be submitted at least 70 days before the scheduled SAWP meeting.

Step 4: Validation and Assessment (Days 1-40)

After submission, EMA validates your request and assigns rapporteurs from EU member state agencies. The assessment phase includes:

• Initial review of briefing document completeness
• Assignment of lead and co-rapporteur
• Preliminary assessment by SAWP members
• Preparation of draft questions for clarification

Step 5: Clarification Questions (Days 40-50)

Approximately 40 days after submission, you may receive clarification questions from the SAWP. These questions help assessors understand your development program and prepare for the discussion meeting.

You typically have 10 days to respond to clarification questions in writing.

Step 6: Discussion Meeting (Day 70)

The discussion meeting brings together sponsor representatives and SAWP members for detailed scientific dialogue. Meeting format options include:

• Face-to-face meetings at EMA in Amsterdam
• Video conference meetings
• Written procedure only (no meeting)

Most sponsors choose the meeting option because it allows real-time discussion and clarification of complex scientific issues.

Step 7: Final Advice Letter (Days 80-100)

After the discussion meeting, SAWP prepares its final recommendations. The process includes:

• SAWP prepares draft advice (Days 70-80)
• CHMP adoption of final advice letter (next CHMP meeting)
• Final advice letter issued to sponsor (within 30 days of CHMP adoption)

The final advice letter provides detailed responses to each question submitted, including specific recommendations, conditions, and follow-up actions.

EMA Scientific Advice Fees

Understanding the EMA advice fee structure helps you budget appropriately for regulatory consultations throughout your development program.

Standard Fee Schedule 2026

Fee Reductions for SMEs

Small and medium-sized enterprises registered with EMA receive significant fee reductions:

To qualify for SME reductions, your company must be registered in the EMA SME register and meet the EU definition for small and medium enterprises.

Fee Reductions for Special Cases

Additional fee reductions apply in specific circumstances:

• Orphan-designated products: 100% fee waiver through Protocol Assistance
• Pandemic products: Fee waivers may apply during declared health emergencies
• Academic sponsors: Reduced fees may be available on a case-by-case basis
• Pediatric-only indications: Certain reductions apply for pediatric development

EMA Scientific Advice vs FDA Type B Meetings

For companies pursuing global regulatory strategies, understanding how European Medicines Agency advice compares to FDA meetings is essential for planning synchronized development programs.

Process Comparison

Key Differences in Approach

The scientific advice procedure at EMA differs fundamentally from FDA meetings in several important ways:

Scope of questions: EMA prefers focused, specific questions that can be answered definitively. FDA Type B meetings allow more exploratory discussion of development options.

Assessment process: EMA advice involves multiple assessors from different member states who must reach consensus. FDA meetings involve the single review division responsible for your application.

Written output: EMA provides a comprehensive advice letter that serves as documented regulatory position. FDA meeting minutes summarize the discussion but may be less detailed.

Follow-up procedures: EMA follow-up advice requires a new formal request. FDA allows informal follow-up through teleconferences and written responses.

When to Use Each Pathway

For more information on FDA meeting types, see our guide on FDA meeting types explained.

Preparing an Effective Scientific Advice Request

The quality of your briefing document directly impacts the value of advice you receive. Follow these best practices to maximize the benefit of your EMA consultation.

Writing Effective Questions

Your questions drive the entire scientific advice process. Effective questions are:

• Specific: Ask about concrete aspects of your development plan, not general strategy
• Answerable: Frame questions so they can receive yes/no or specific recommendations
• Prioritized: Lead with your most critical questions in case time is limited
• Contextual: Provide sufficient background for assessors to understand the issue

Example of a weak question:

"What clinical development program does EMA recommend for our product?"

Example of a strong question:

"Does EMA agree that a single pivotal Phase 3 trial with 500 patients, using progression-free survival as the primary endpoint and overall survival as the key secondary endpoint, is an acceptable basis for marketing authorization in [specific indication]?"

Briefing Document Best Practices

Common Mistakes to Avoid

Avoid these frequent errors in scientific advice requests:

1. Submitting too many questions: Focus on 3-5 critical questions maximum
2. Asking questions too early: Wait until you have data to support meaningful discussion
3. Ignoring previous advice: Address any follow-up from prior consultations
4. Missing deadlines: Late submissions result in postponed meetings
5. Inadequate preparation for discussion: Practice responses to anticipated questions

Follow-up Advice and Maintaining Regulatory Alignment

Scientific advice is not a one-time event. As your development program evolves, maintaining alignment with regulatory expectations requires ongoing engagement with EMA.

When to Request Follow-up Advice

Consider requesting follow-up scientific advice when:

• Your development program changes significantly from the original advice
• New data raise questions about the agreed approach
• Regulatory guidance has been updated affecting your program
• You are preparing for a major milestone (Phase 3 initiation, MAA submission)

Tracking Advice Implementation

Document how you implemented scientific advice recommendations and any deviations from the agreed approach. This information will be important for:

• Preparing your marketing authorization application
• Responding to assessment questions during MAA review
• Demonstrating due diligence in regulatory interactions

Key Takeaways

Next Steps

Understanding EMA scientific advice procedures is essential for any company targeting European marketing authorization. The structured consultation process helps align your development strategy with regulatory expectations before you commit to expensive late-stage trials.

Organizations managing regulatory submissions benefit from automated validation tools that catch errors before gateway rejection. Assyro's AI-powered platform validates eCTD submissions against FDA, EMA, and Health Canada requirements, providing detailed error reports and remediation guidance before submission.

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