Challenges of Global Studies in EFSA Health Claims: Key Considerations

Navigating Global Studies in EFSA Health Claim Applications

Exploring the impact of studies conducted outside of Europe on EFSA health claim applications. Our regulatory expert, Steve, shares insights on how EFSA evaluates the weight and influence of global studies in the review process.

Table of Contents

• No Mandate for European-Only Studies
• Dietary and Cultural Differences Matter
• Scenario 1: Two European Studies, One Indian Study
• Scenario 2: One European, One US, One Indian Study
• Blending Global Studies Can Work, But Challenges Remain
• Reproducible Cause and Effect in the Target Population
• No Mandate, But Regulators Remain Cautious
• Key takeaways
• FAQ

No Mandate for European-Only Studies

There is no EFSA mandate that restricts the consideration of studies conducted solely within Europe for health claim applications. The weight given to any study is contingent upon certain key factors.

Geographical Influence

The geographical location of the studies plays a significant role in determining their weight in the evaluation process.

Key Considerations

• Dietary differences
• Cultural disparities

Study Weight Determinants

The weight given to studies is contingent upon certain key factors.

Dietary and Cultural Differences Matter

When considering studies conducted outside of Europe, it's crucial to address dietary and cultural differences. These variations play a pivotal role in the evaluation process for health claim applications.

Dietary Disparities

Differences in protein intake and the prevalence of processed foods are notable aspects of dietary variations across different countries.

Cultural Variances

Cultural disparities, such as the Mediterranean diet in certain regions of southern Europe, significantly impact the assessment of studies.

Scenario 1: Two European Studies, One Indian Study

Let's consider a scenario where there are two studies conducted in Europe at the same site, and one study completed at a site in India. How would EFSA review or perceive these studies during the evaluation process?

Assumptions and Influences

Before delving into the review process, it's essential to establish certain fundamental assumptions and rule out potential influences. Assuming all the studies demonstrate a positive, statistically significant difference in favor of the product, and there are no methodological weaknesses, the focus shifts to comparing the geographical locations of the studies.

European Studies' Considerations

• Reproducibility concerns due to same site
• Need for additional support

Influence of Indian Study

The study conducted in India could potentially contribute to the evaluation process if it effectively addresses cultural and dietary differences. However, the reliance on an overseas study may weaken the overall package.

Scenario 2: One European, One US, One Indian Study

Now, let's explore a scenario where there is one study conducted in Europe, one in the US, and one in India. How would this combination of studies be perceived during the EFSA review process?

Study Quantity and Geographic Distribution

The presence of three studies, with only one in the European population, may not be considered an ideal package of data. EFSA often favors a higher quantity of studies, typically falling within the range of three to five, for a more successful evaluation.

Comparability and Potential Differences

The comparability of the studies conducted in India and the US becomes crucial in eliminating potential differences in dietary lifestyle, such as diet and exercise, which could influence the evaluation process.

Blending Global Studies Can Work, But Challenges Remain

Blending studies from outside of the European population with those conducted within Europe presents challenges, especially if all studies were performed outside of Europe. However, with careful management of differences, blending them may not pose a significant problem.

Addressing Differences

Managing dietary and cultural disparities between different populations is crucial in blending global studies for EFSA health claim applications. It's essential to control for methodological limitations and openly address any differences between the sites and populations included in the dossier.

Reproducible Cause and Effect in the Target Population

Proving reproducible cause and effect for an EFSA health claim in the target population is vital. This not only applies to demonstrating the physiological health benefit but also the geographical relevance.

No Mandate, But Regulators Remain Cautious

EFSA does not have a mandate that limits the consideration of studies conducted solely within Europe for health claim applications. However, regulators remain cautious and consider certain key factors when evaluating global studies in EFSA health claim applications.

Regulatory Caution

Regulators exercise caution and consider various factors when evaluating the weight and influence of global studies in the review process for EFSA health claim applications.

Key Factors for Consideration

• Geographical influence
• Dietary and cultural disparities
• Methodological limitations

Addressing Global Study Challenges

Regulators are mindful of the challenges associated with blending global studies and remain vigilant in ensuring the reliability and relevance of the data in EFSA health claim applications.

Key Takeaways

1. No European-Only Mandate: EFSA does not mandate studies to be conducted only within Europe; however, geographical influence and cultural differences are critical factors.
2. Dietary and Cultural Considerations: Differences in diet and culture between regions must be addressed to ensure study relevance and credibility.
3. Balancing Global Studies: Blending studies from various regions can work, but managing differences and maintaining methodological rigor is essential.
4. Regulatory Caution: EFSA evaluates the reliability and relevance of global studies cautiously, considering dietary, cultural, and methodological factors.

FAQ

Geographical Influence on Studies

When it comes to studies conducted outside of Europe, the geographical influence plays a significant role in determining their weight in the evaluation process for EFSA health claim applications. The weight given to any study is contingent upon certain key factors, particularly related to the geographical location of the studies.

Dietary and Cultural Disparities

• Differences in protein intake across countries
• Impact of processed foods on dietary variations
• Cultural disparities and their influence on study assessment

Reviewing Studies: European vs. Non-European

How are studies conducted in different geographical locations perceived during the EFSA review process? Let's explore the potential influences and assumptions that underpin the evaluation of studies from diverse locations.

Blending Global Studies for EFSA Health Claims

Challenges and considerations when blending studies from outside of the European population with those conducted within Europe for EFSA health claim applications. Addressing differences and methodological limitations is crucial for a successful integration of global studies.

Regulatory Caution and Key Considerations

• Geographical influence on study weight
• Addressing dietary and cultural disparities
• Regulatory vigilance in ensuring data reliability and relevance for EFSA health claim applications

Role of Pre-clinical Data in Crafting Persuasive EFSA Health Claims

For more information on the role of pre-clinical data in crafting a persuasive EFSA health claim application, you can refer to our previous blog post in Atlantia's EFSA Health Claims FAQ series here.