Regulatory GCP Signals for 2026: An Expert Analysis
Written by Maxim Bunimovich,
independent GCP auditor and clinical research expert at The QARP.
Written by Maxim Bunimovich,
independent GCP auditor and clinical research expert at The QARP.
This report draws on key regulatory updates from the Food and Drug Administration (FDA) Bioresearch Monitoring (BIMO) program and the European Medicines Agency (EMA) to detail the precise operational focus for Good Clinical Practice (GCP) compliance expected in 2026.
I. Regulatory Publications Shaping 2026 GCP Expectations
Official guidance released in the first half of 2025 defines how existing regulatory obligations will be systematically evaluated by regulators in the coming year.
1. ICH E6(R3) Final Guideline (January 2025)
The modernization of GCP, reflected in ICH E6(R3) Principles and Annex 1, reached Step 5 (including CHMP endorsement) in January 2025. The update aims to facilitate a more proportionate application of its principles and enable the use of alternative trial types/technologies.
This modernization strongly emphasizes three core areas for sponsors and Contract Research Organizations (CROs):
• Risk-Proportionality: Requiring the early identification of critical-to-quality factors and the proportional application of GCP principles across study design, monitoring, and data management.
• System Integrity: Mandating rigorous, lifecycle-based oversight of computerized systems, which includes processes for validation, metadata management, and audit trails. This commitment is essential for supporting new study models coupled with direct digital data accrual.
2. FDA BIMO Compliance Programs (2020–2025 Revisions)
FDA’s Bioresearch Monitoring (BIMO) program ensures the protection of subjects’ rights, safety, and welfare, and verifies the accuracy and reliability of study data submitted to the Agency. Inspection assignments cover sponsors, CROs, clinical investigators (CIs), and Institutional Review Boards (IRBs). The issuance of the revised IRB Compliance Program (CP 7348.809) in April 2025 marks a formal endpoint for defining expectations within this critical compliance area.
FDA inspections focus on the sponsor’s overall practices and procedures, particularly regarding clinical trial oversight. Key inspectional objectives include:
• Subject Safety and Welfare: This remains the primary objective for BIMO inspections. IRB inspections specifically evaluate compliance with 21 CFR 50 and 56 to ensure human subject protection.
• Data Reliability: Verifying the integrity of study data submitted in support of research or marketing applications. Full narrative reporting of any regulatory deviations or significant concerns related to data reliability must be thoroughly documented in the Establishment Inspection Report (EIR).
• Oversight and Accountability: Evaluating practices related to site monitoring, vendor audits, training, and data collection. Sponsors bear the ultimate responsibility for compliance, even if obligations are transferred in writing to a CRO.
3. EMA Mid-Year Report 2025 (January–June)
The EMA’s report highlights the full application of the Clinical Trials Regulation (CTR) in January 2025, concluding the three-year transition period. The transition ensures that the Clinical Trials Information System (CTIS) functions as the single-entry point for sponsors and regulators for submissions and assessments across the EU.
The implementation of the CTR, supported by the Accelerating Clinical Trials in the EU (ACT EU) initiative, places explicit focus on:
• Enhanced EU Governance and Consistency: Working to strengthen EU level governance of CT and ensure the consistent process execution of clinical trials across Member States.
• Transparency and Public Access: The launch of a new clinical trial map on the CTIS public website provides patients and healthcare professionals with comprehensive, real-time information. This includes investigators’ contact details, enabling direct public inquiries about potential trial enrolment.
II. Expert-Level Operational Signals for 2026
Based on the detailed guidance provided by the FDA CPs and the fully matured CTR environment in the EU, operations in 2026 will be defined by rigorous demonstration of compliance rather than mere documentation existence:
I. Regulatory Publications Shaping 2026 GCP Expectations
Official guidance released in the first half of 2025 defines how existing regulatory obligations will be systematically evaluated by regulators in the coming year.
1. ICH E6(R3) Final Guideline (January 2025)
The modernization of GCP, reflected in ICH E6(R3) Principles and Annex 1, reached Step 5 (including CHMP endorsement) in January 2025. The update aims to facilitate a more proportionate application of its principles and enable the use of alternative trial types/technologies.
This modernization strongly emphasizes three core areas for sponsors and Contract Research Organizations (CROs):
• Risk-Proportionality: Requiring the early identification of critical-to-quality factors and the proportional application of GCP principles across study design, monitoring, and data management.
• System Integrity: Mandating rigorous, lifecycle-based oversight of computerized systems, which includes processes for validation, metadata management, and audit trails. This commitment is essential for supporting new study models coupled with direct digital data accrual.
2. FDA BIMO Compliance Programs (2020–2025 Revisions)
FDA’s Bioresearch Monitoring (BIMO) program ensures the protection of subjects’ rights, safety, and welfare, and verifies the accuracy and reliability of study data submitted to the Agency. Inspection assignments cover sponsors, CROs, clinical investigators (CIs), and Institutional Review Boards (IRBs). The issuance of the revised IRB Compliance Program (CP 7348.809) in April 2025 marks a formal endpoint for defining expectations within this critical compliance area.
FDA inspections focus on the sponsor’s overall practices and procedures, particularly regarding clinical trial oversight. Key inspectional objectives include:
• Subject Safety and Welfare: This remains the primary objective for BIMO inspections. IRB inspections specifically evaluate compliance with 21 CFR 50 and 56 to ensure human subject protection.
• Data Reliability: Verifying the integrity of study data submitted in support of research or marketing applications. Full narrative reporting of any regulatory deviations or significant concerns related to data reliability must be thoroughly documented in the Establishment Inspection Report (EIR).
• Oversight and Accountability: Evaluating practices related to site monitoring, vendor audits, training, and data collection. Sponsors bear the ultimate responsibility for compliance, even if obligations are transferred in writing to a CRO.
3. EMA Mid-Year Report 2025 (January–June)
The EMA’s report highlights the full application of the Clinical Trials Regulation (CTR) in January 2025, concluding the three-year transition period. The transition ensures that the Clinical Trials Information System (CTIS) functions as the single-entry point for sponsors and regulators for submissions and assessments across the EU.
The implementation of the CTR, supported by the Accelerating Clinical Trials in the EU (ACT EU) initiative, places explicit focus on:
• Enhanced EU Governance and Consistency: Working to strengthen EU level governance of CT and ensure the consistent process execution of clinical trials across Member States.
• Transparency and Public Access: The launch of a new clinical trial map on the CTIS public website provides patients and healthcare professionals with comprehensive, real-time information. This includes investigators’ contact details, enabling direct public inquiries about potential trial enrolment.
II. Expert-Level Operational Signals for 2026
Based on the detailed guidance provided by the FDA CPs and the fully matured CTR environment in the EU, operations in 2026 will be defined by rigorous demonstration of compliance rather than mere documentation existence:
Conclusion
This comprehensive approach highlights that regulatory bodies are moving away from surface-level review towards inspecting the underlying management systems and technical infrastructure that ensure both ethical conduct and data quality.
Analogy: Compliance in 2026 is less like checking a final exam for a passing grade, and more like auditing the entire educational system—ensuring the teacher was qualified, the curriculum was followed, and the student's work was protected from external influence, from the moment they first enrolled to the moment the final data was locked.
This comprehensive approach highlights that regulatory bodies are moving away from surface-level review towards inspecting the underlying management systems and technical infrastructure that ensure both ethical conduct and data quality.
Analogy: Compliance in 2026 is less like checking a final exam for a passing grade, and more like auditing the entire educational system—ensuring the teacher was qualified, the curriculum was followed, and the student's work was protected from external influence, from the moment they first enrolled to the moment the final data was locked.