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We explore what has changed in ICH E6(R3) regarding QbD (especially in relation to ICH E8(R1)), address common challenges and misconceptions in applying QbD, share real-world examples, and provide a practical checklist for implementing QbD in trial planning and execution.

The draft revision of ICH GCP E6 ("R3", published 19 May 2023) refines the expectations for Quality Assurance (QA) and expands the framework for identifying, reporting, and remediating non‑compliance.

The updated Section 2.12 of GCP E6(R3) brings clearer responsibilities for investigators regarding data integrity, source records, and system management. Investigators are now formally accountable for data accuracy—regardless of who manages the system.

EMANS-2028 marks a fundamental shift in how regulation supports medicines development across the EU.
It’s not just about access or innovation anymore — it’s about structural readiness: resilient supply, cross-sector health impact, and the digital maturity of those bringing therapies to market.

Regional Differences and Operational Challenges. This article explores the regional differences in serious breach reporting obligations, the operational complexities involved in defining the notification timeline—particularly the concept of “Day Zero”—and the coordination challenges between sponsors and CROs.

The upcoming implementation of ICH GCP R3 introduces changes that auditors and quality assurance teams must carefully consider. To support clear understanding and effective implementation, the following table summarizes key updates from ICH GCP R2 to R3 regarding audit requirements

Informed consent is a foundational pillar of clinical research, ensuring participants fully understand the scope, risks, and benefits of a study before enrollment.

Sponsor oversight and vendor management consistently rank among the top reasons for inspection findings under E6(R2) and even earlier.

With the release of ICH GCP (Good Clinical Practice) E6(R3), sponsors and investigators are revisiting how they define and handle protocol deviations.