GxP Signal of the Week (EMA/FDA/ICH only)
2026 opens with several important regulatory shifts: FDA’s transition to the QMSR for medical devices, a stronger GCP focus on ICH E6(R3) and EMA/FDA joint AI principles.
- EMA confirmsEMA confirms ICH E6 as the key scientific guideline on Good Clinical Practice; the revised ICH E6(R3), with its emphasis on a risk‑based and technology‑neutral approach, is available on EMA’s ICH E6 guideline page.
- EMA’s formalEMA’s formal GCP inspection framework (coordination, conduct, reporting) is described in the “Good clinical practice (GCP) inspection procedures” section and related INS/GCP documents, which set expectations for applicants and inspectors.
- Process mappingWhether internal GCP processes are explicitly mapped to ICH E6(R3) principles, including risk-based oversight, use of digital solutions, and vendor management frameworks
- Inspection alignmentHow well inspection preparation and conduct procedures align with EMA's GCP inspection procedures and FDA's GCP expectations for clinical trials.
EMA and FDA have published a joint news item, "EMA and FDA set common principles for AI in medicine development", outlining guiding principles for responsible AI use across the medicinal product lifecycle. The communication highlights the need for robust data governance (quality, traceability, validation), lifecycle management of AI/ML models, transparency, and preservation of meaningful human oversight.
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Data governanceQuality, traceability, and validation of data used in AI/ML systems
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Lifecycle managementOngoing oversight of AI/ML models throughout their operational life
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TransparencyClear documentation and explainability of AI decision-making processes
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Human oversightPreservation of meaningful human control and review of AI outputs
What QA/Statistics/Clinical Operations should review
01
AI/ML inventory
Whether there is an internal register of AI/ML tools used in GxP processes (clinical, statistical, data analytics) and how it aligns with the EMA/FDA guiding principles.
02
QMS integration
How AI-related risks are integrated into QMS and QRM (processes, SOPs, validation, change control, training), with the ability to reference the EMA/FDA principles where necessary.
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GCP alignmentAlign internal processes with ICH E6(R3), EMA GCP inspection procedures, and FDA's GCP/clinical trials section, with explicit references in methodology documents
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QMSR gap analysisComplete or plan a QMSR gap analysis using the FDA QMSR FAQ and final rule as the primary reference set for compliance readiness.
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AI governanceDefine internal rules for AI use, referencing the official EMA/FDA communication on AI principles in medicine development
- EMA ICH E6 guideline page: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline
- EMA GCP inspection procedures: EMA GCP inspection framework
- FDA QMSR final rule FAQ: FDA QMSR resourse
- EMA/FDA AI principles: Joint AI communication