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.
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Articles tagged with “pharmaceutical-regulation”
Japan's Drug Approval Process: A Guide to PMDA & MHLW
Learn about Japan's drug approval process. This guide covers the PMDA & MHLW roles, review timelines, drug lag, and expedited pathways like SAKIGAKE.
The EU AI Act & Pharma: Compliance Guide + Flowchart
Learn about the EU AI Act's impact on pharma. This guide explains the risk-based approach, high-risk AI rules, and compliance steps with a free flowchart & SOP
ICH M7: A Guide to Mutagenic Impurity Assessment Software
Understand the ICH M7 guideline for assessing and controlling mutagenic impurities in pharmaceuticals using in silico (Q)SAR software, TTC, and risk-based metho
Automating Audit Trail Compliance for 21 CFR Part 11 & Annex 11
An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.