Articles tagged with “pharmaceutical-regulation”

Examine the January 2025 FDA draft guidance on AI in drug development. This report details the 7-step credibility framework and excluded AI applications.

Learn about the ICH M8 eCTD v4.0 submission specification. This guide covers its technical basis in HL7 RPS, file requirements, and global adoption timelines.

Get an in-depth comparison of eCTD software for regulatory submissions. This guide analyzes top platforms like Veeva & EXTEDO on features, pricing, & eCTD v4.0

An educational guide to generic drug patent challenges. Learn about the Hatch-Waxman Act, the ANDA pathway, Paragraph IV certifications, and the FDA Orange Book

An in-depth comparison of the FDA and EMA, updated for 2026. Learn the key differences in US and EU drug approval processes, review timelines, GMP, FDORA reforms, EU pharma legislation overhaul, and regulatory frameworks.

Learn about Japan's drug approval process, updated for 2026. This guide covers PMDA & MHLW roles, review timelines, drug lag, the 2025 PMD Act amendments, eCTD v4.0 mandate, and expedited pathways like SAKIGAKE.

Learn about the EU AI Act's impact on pharma. Updated for 2026 with the Digital Omnibus proposal, GPAI Code of Practice, and revised Product Liability Directive. Includes risk classification, compliance steps, flowchart & SOP starter kit.

Updated 2026 guide to ICH M7 mutagenic impurity assessment software including Derek Nexus 6.5, Sarah Nexus 5.1, Leadscope 2025.0, OECD QSAR Toolbox 4.8, AmesNet deep learning, and nitrosamine regulatory developments.

An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies, data integrity measures, and the latest 2025-2026 regulatory developments including the Annex 11 draft revision and FDA CSA guidance.