Regulatory Updates
Timely summaries of regulatory developments affecting clinical trial design, site operations, and compliance requirements across global markets.
Latest Updates
Our regulatory affairs team monitors FDA, EMA, ICH, and other global regulatory bodies to identify developments with direct impact on site operations and trial execution.
ICH M11 CeSHarP: Standardized Electronic Protocol Template Adopted Globally
The FDA's Federal Register publication of the ICH M11 Clinical Electronic Structured Harmonised Protocol marks a fundamental shift toward machine-readable, standardized clinical trial protocols across ICH member regulators. Sites and sponsors should plan for a multi-year voluntary adoption window leading to a recommended-default phase in 2028.
FDA Guidance on Artificial Intelligence in Drug and Biological Product Development
Analysis of the FDA's draft and forthcoming final guidance on AI to support regulatory decision making, including the 7-step credibility framework, the joint FDA/EMA Guiding Principles published January 2026, and the AI-Enabled Optimization of Early-Phase Clinical Trials pilot program.
FDA Finalizes Guidance on Diversity Action Plans for Clinical Studies
The FDA has finalized its guidance requiring sponsors to submit diversity action plans for Phase III trials and certain late-stage Phase II studies. Sites should prepare for increased data collection requirements around demographic enrollment targets and community engagement activities.
ICH E6(R3) Implementation Timeline Announced
The ICH has published the implementation timeline for E6(R3), the updated Good Clinical Practice guideline. Sites have a 24-month transition period to adopt the new risk-proportionate approach to clinical trial quality management. Key changes include enhanced requirements for quality tolerance limits and centralized monitoring.
EU Clinical Trials Regulation: Updated Requirements for CTIS Submissions
The European Medicines Agency has released updated technical specifications for the Clinical Trials Information System. Sponsors conducting multi-country EU trials should review revised requirements for protocol amendments, safety reporting, and annual reporting through the centralized portal.
Draft Guidance on Decentralized Clinical Trials: Operational Considerations
The FDA has issued draft guidance addressing operational considerations for decentralized and hybrid clinical trial designs, including expectations for remote informed consent, direct-to-patient drug shipment, and telehealth visit documentation standards.
Regulatory Focus Areas
We track regulatory developments across several key domains that directly affect site readiness and sponsor compliance strategies.
ICH E6(R3) implementation, risk-based quality management, investigator oversight requirements, and evolving expectations for electronic source documentation.
Safety reporting timelines, SUSAR notification requirements, DSMC best practices, and pharmacovigilance obligations for investigators and sites.
ALCOA+ principles for electronic data, 21 CFR Part 11 compliance, GDPR requirements for clinical data, and emerging frameworks for real-world data governance.
Network Readiness Support
When significant regulatory changes are announced, our team provides structured support to help network sites prepare and adapt.
Stay Ahead of Regulatory Changes
Subscribe to our regulatory update alerts and ensure your site is always prepared for evolving compliance requirements.