Articles tagged with “fda-vs-ema”

Global Regulatory Submissions: ICH vs Regional Rules

Analyze global regulatory submissions, contrasting ICH guidelines with regional requirements. Learn to manage FDA, EMA, and local filing differences.

35 min read

2/2/2026

regulatory submissions ich guidelines ectd format global regulatory affairs pharmaceutical compliance ctd dossier fda vs ema drug registration

FDA vs. EMA: Key Differences in US & EU Drug Regulation

An in-depth comparison of the FDA and EMA. Learn the key differences in US and EU drug approval processes, review timelines, GMP, and regulatory frameworks.

55 min read

11/18/2025

fda vs ema drug approval process pharmaceutical regulation regulatory affairs nda vs maa good manufacturing practice us drug regulation eu drug regulation