Understanding the regulatory requirements for Chemistry, Manufacturing, and Controls (CMC) is crucial for global product success. Here’s a quick comparison between the US FDA and European EMA regulations:
Regulatory Authorities
- US: FDA (Food and Drug Administration)
- EU: EMA (European Medicines Agency)
Submission Format
- US: eCTD (Electronic Common Technical Document)
- EU: eCTD, with additional local requirements for certain member states
Quality Guidelines
- US: ICH guidelines adopted, with FDA-specific requirements (e.g., 21 CFR Part 211)
- EU: ICH guidelines adopted, compliance with EU GMP (EudraLex Vol. 4)
Post-Approval Changes
- US: CBE-30, CBE-0, PAS (Changes Being Effected or Prior Approval Supplements)
- EU: Type IA, IB, and II variations (based on impact level)
Stability Testing Requirements
- US: Requires compliance with ICH and FDA Guidance for Industry on Stability
- EU: Follows ICH, with EU-specific climate zone considerations
Market Approval Pathways
- US: NDA (New Drug Application) or BLA (Biologics License Application)
- EU: Centralized, Decentralized, or Mutual Recognition Procedures
Key Takeaways
- Both markets emphasize ICH guidelines but have unique regulatory nuances.
- Understanding post-approval change requirements is essential for maintaining compliance.
- Harmonization efforts between FDA and EMA are ongoing, but local variations remain.
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Resource Person: Pratik Pawar