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.

45 min read

10/27/2025

japan drug approval process pmda mhlw pharmaceutical regulation drug lag sakigake designation pmd act regulatory affairs japan

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

35 min read

10/18/2025

eu ai act pharmaceutical regulation ai in pharma high-risk ai compliance sop medical device regulation gxp

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

30 min read

10/14/2025

ich m7 mutagenic impurities qsar modeling in silico toxicology genotoxicity drug safety pharmaceutical regulation

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.

50 min read

8/4/2025

21 cfr part 11 eu annex 11 audit trails data integrity gxp compliance pharmaceutical regulation system validation e-signatures