In less than a year, two major updates to Quality regulations will go into effect in the European Union and United States. ICH E6 (R3) GCP Guideline will be effective in the EU as of 23 July, 2025, while FDA’s implementation date for this guidance remains uncertain.1 No matter the implementation date for ICH E6 (R3) in the US, FDA’s new Quality Management System Regulation (QMSR) goes into effect 02 Feb 2026.2 Both of these signal a shift in Regulator’s thinking and enforcement when it comes to risk-based quality management and a product lifecycle approach to safety and efficacy. To be ready for the change, sponsors, CROs, and CDMOs need to take a hard look at their risk assessment policies, their controls for investigational product quality, and monitoring processes for clinical data integrity and patient safety.
There is significant alignment between ICH E6 (R3) and QMSR when it comes to encouraging quality by design (QbD), continuous improvement, and risk monitoring. This greater emphasis on proactive risk management translates to more rigorous risk assessments for clinical protocols and a call for stronger control over investigational product quality. This is backed up by enhanced monitoring expectations for clinical data integrity and patient safety data.
The alignment between these new regulations, as well as their integration of ISO standards, mean that new trials will benefit from better harmonized processes across regions and fewer regulatory discrepancies. This can lead to accelerated site qualification, better aligned monitoring processes, and more similar inspection procedures. The good news extends to the fact that these new regulations introduce significantly more flexibility into trial design and adaptability.
Sponsors, CROs, and CDMOs can take several proactive steps to ensure their quality systems and risk management practices give them a competitive advantage in this new environment:
- Work with industry experts and technologists to ensure solid processes and technologies support source data verification (SDV) and audit trails for clinical data handling.
- Invest early in creating clear SOPs and supporting systems for deviation investigations and CAPA management, ensuring control over investigational product quality.
- Collaborate with independent service providers to enhance supplier and vendor controls, from vendor selection through contracting, monitoring and governance.
- Invest in inspection readiness training across GLP, GCP, and PV organizations to maintain inspection-ready data and documentation at all times.
- For smaller firms early in the development process who may not have a fully built out Quality department, invest in fractional Quality support from seasoned industry veterans.
- Audit your risk management processes and ensure there is a continuous feedback loop as Critical to Quality (CTQ) factors are identified and evolve.
By taking these steps, all parties involved in drug development can set themselves up to accelerate progress towards clinical milestones and eventual candidate approval, while taking advantage of the harmonized processes and increased flexibility inherent in the new, risk-based regulations.
References:
1 Kim, J. and Livornese, D. (2025, Feb 28). The ICH E6(R3) Guidelines: A Major Update to Good Clinical Practice. FDA Law Blog, Hyman, Phelps & MacNamara. https://www.thefdalawblog.com/2025/02/the-ich-e6r3-guideline-a-major-update-to-good-clinical-practice/
2 US Food and Drug Administration. (2024, Nov 21). Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions. FDA. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
