In global regulatory affairs, one of the most complex challenges we face is resolving conflicting requirements from different regulatory bodies. Each agency has its own set of expectations, shaped by regional regulations, scientific perspectives, and risk tolerance. Navigating these differences requires a strategic, risk-based approach to ensure compliance while maintaining efficiency.
A Real-World Example: FDA vs. EMA Stability Requirements
Consider a scenario where a company is submitting a biologic product dossier to both the FDA (U.S.) and EMA (Europe).
- The FDA requires 12 months of real-time stability data at the time of submission.
- The EMA, on the other hand, expects at least 6 months of real-time data but may allow an approach where ongoing stability data can be submitted post-approval under conditions agreed upon with regulators.
Conflict: If the company follows the FDA’s requirement, the submission could be delayed by 6 months, impacting market entry in both the U.S. and Europe. However, if they follow the EMA’s approach, the FDA might consider the submission insufficient.
How to Resolve This Conflict?
Identify & Assess the Regulatory Impact
- Regulatory Intelligence: Analyze guidelines (ICH Q1A for stability), past approvals, and industry best practices.
- Business Impact: Determine how a delay in one region affects global commercialization plans.
Engage with Regulatory Authorities
- Scientific Advice Meetings: Request meetings with both the FDA and EMA to discuss a harmonized approach.
- Use a Bridging Justification: Propose using 6 months of real-time data with 12 months of accelerated stability as an interim measure, backed by historical data from similar products.
Develop a Risk-Based Submission Strategy
- Phased Submission Approach: Submit with available stability data and commit to submitting additional real-time data post-submission.
- Global vs. Regional Variations: If alignment isn’t possible, prepare different data packages for each region while ensuring the core stability strategy remains scientifically sound.
Internal Communication & Documentation
- Align regulatory, quality, and manufacturing teams to ensure consistency in responses.
- Document regulatory justifications for future inspections or variations.
Stay Agile & Monitor Regulatory Trends
- Regulations evolve—continuous monitoring of agency feedback and industry trends helps in future submissions.
- Engage in industry working groups to stay informed on changing regulatory expectations.
Outcome & Learning
By leveraging a scientific and risk-based approach, the company can achieve:
- Faster regulatory approval without unnecessary delays.
- Compliance with both FDA and EMA expectations.
- A precedent for future submissions, reducing regulatory uncertainty.
Read also:
- Understanding Patent Length and Generic Competition in Pharmaceuticals
- Regulatory Strategies for Excipient Grade Changes Across Global Markets
Resource Person: Pratik Pawar