Regulatory Intelligence Feed
Monitor regulatory updates across global health authorities affecting your clinical trials.
Updated Requirements for Clinical Trial Authorization Applications in the UAE
The UAE Department of Health has issued comprehensive updates to clinical trial authorization requirements effective immediately. Key changes include mandatory electronic submission of all CTA documents, enhanced informed consent requirements with Arabic language provisions, new principal investigator qualification criteria, and updated facility inspection standards. Sponsors must transition to the new eCTD format within 90 days.
Administrative Update: Revised Fee Schedule for Clinical Trial Applications
The UAE DoH has published updated fee schedules for clinical trial applications, amendments, and annual renewals. Fee adjustments range from 5-15% increase across categories. New expedited review fee tier introduced for breakthrough therapy designated trials.
FDA Safety Communication: New Monitoring Requirements for Cardiovascular Drug Trials
The FDA has issued a safety communication requiring enhanced cardiac monitoring in all Phase II and Phase III trials involving cardiovascular agents. New requirements mandate continuous telemetry for the first 72 hours post-dose, mandatory troponin monitoring at specified intervals, and independent DSMB review of all cardiac events within 48 hours of occurrence. Applies to all active INDs.
DoH Portal Maintenance: New Electronic Submission System Launch
The UAE DoH announces the launch of a new electronic submission portal for clinical trial applications. The legacy system will be decommissioned on the specified date. Training materials and webinar registration links provided. Migration of existing applications will be handled automatically.
Revised Guideline on Clinical Investigation of Medicinal Products for Acute Coronary Syndromes
The EMA has published revised guidance on ACS clinical trials, updating endpoint definitions, minimum follow-up durations, and statistical considerations. The guideline introduces a composite primary endpoint hierarchy and provides updated recommendations for enrichment strategies and adaptive designs in ACS populations.
SFDA Implements New Good Clinical Practice Requirements for All Clinical Trials
The Saudi Food and Drug Authority has released updated GCP requirements aligned with ICH E6(R3). Major changes include enhanced risk-based monitoring, mandatory electronic informed consent capability, updated investigator site qualification requirements, and new data integrity provisions. All active trials must demonstrate compliance within 180 days of publication.
SFDA Workshop: Implementation of Risk-Based Monitoring
The SFDA is hosting a series of workshops on implementing risk-based monitoring approaches aligned with ICH E6(R3). Workshop covers practical risk assessment tools, centralized monitoring techniques, and documentation expectations. Registration open for clinical operations teams.
ICH E6(R3) Good Clinical Practice – Step 4 Final Version Published
The International Council for Harmonisation has published the final Step 4 version of E6(R3), the comprehensive revision of the GCP guideline. Key updates include a proportionate, risk-based approach to clinical trial conduct, integration of digital technologies, updated requirements for electronic records and data governance, and enhanced oversight of third-party service providers.
FDA Announces New Division Director for Cardiovascular and Renal Products
The FDA Center for Drug Evaluation and Research has announced a new division director for the Office of Cardiology, Hematology, Endocrinology, and Nephrology. The appointment is effective immediately. No policy changes anticipated during transition period.
Draft Reflection Paper on Use of AI/ML in Clinical Trial Design and Conduct
The EMA has released a draft reflection paper seeking stakeholder input on the use of artificial intelligence and machine learning technologies in clinical trial design, patient selection, and real-time data analysis. Consultation period open for 6 months. Addresses algorithmic transparency, validation requirements, and regulatory oversight.
WHO Technical Report: Harmonized Standards for Multi-Regional Clinical Trials
The WHO has published a technical report providing harmonized standards for the design and conduct of multi-regional clinical trials (MRCTs). Addresses sample size allocation across regions, ethnic sensitivity assessment, consistent regulatory submission strategies, and data sharing frameworks across participating health authorities.
Circular: Updated Requirements for Principal Investigator Qualifications
The UAE DoH has circulated updated minimum qualification requirements for principal investigators conducting clinical trials in the UAE. New requirements include mandatory completion of advanced GCP certification, minimum years of sub-specialty experience adjusted by trial phase, and new requirements for PIs conducting trials in specialized therapeutic areas.
SFDA Guidance on Electronic Informed Consent in Clinical Trials
The SFDA has published detailed guidance on the use of electronic informed consent (eConsent) in clinical trials conducted in Saudi Arabia. The guidance covers technical requirements for eConsent platforms, identity verification provisions, Arabic language interface requirements, and data security standards compliant with Saudi data protection regulations.
FDA Draft Guidance: Adaptive and Platform Trial Designs for Oncology
The FDA has issued draft guidance clarifying expectations for adaptive and platform trial designs in oncology drug development. Addresses biomarker-driven enrichment, dose optimization integration, master protocol statistical frameworks, and regulatory considerations for adding or removing treatment arms during conduct.
Updated Requirements for Pharmacovigilance in Clinical Trials
EMA has updated pharmacovigilance requirements for clinical trials in the EU, including enhanced SUSAR reporting timelines, mandatory electronic reporting through EudraVigilance, and new signal detection requirements during ongoing trials. Updated aggregate safety reporting formats are also specified.
EMA Public Consultation: Revision of Clinical Trial Regulation Templates
The EMA has opened a public consultation on proposed revisions to the standardized templates used for Clinical Trial Application submissions. Changes focus on simplifying administrative sections, harmonizing data formats across member states, and integrating digital signature requirements.
DoH Recognized Ethics Committee List Updated
The UAE DoH has published an updated list of recognized ethics committees approved to review clinical trial applications. Two new institutional ethics committees have been added and one has been placed under provisional status pending re-accreditation review.
SFDA Annual Report: Clinical Trial Activity in Saudi Arabia 2025
The SFDA has published its annual report on clinical trial activity, reporting a 23% increase in CTA submissions and 18% increase in approved trials. Report highlights growth in oncology and metabolic disease trials, increased participation of Saudi national investigators, and improved approval timelines.
FDA Q&A: Electronic Submissions Technical Specifications Update
The FDA has published updated Q&A on electronic submission technical specifications, addressing common questions about eCTD v4.0 implementation, PDF formatting requirements, and electronic signature validation. Includes troubleshooting guidance for common submission errors.
WHO Prequalification: Updated List of Reference Products
The WHO has updated its list of reference products used for prequalification of generic medicines. Several cardiovascular and diabetes medications have been added or updated. The list supports global harmonization of bioequivalence study requirements.
DoH Hosts Regional Clinical Research Conference 2026
The UAE Department of Health announces the Regional Clinical Research Conference scheduled for Q3 2026. Topics include regulatory harmonization across GCC countries, bioequivalence study requirements, and digital health technology integration in clinical trials. Abstract submissions are open.
SFDA Updates: Import License Requirements for Investigational Products
The SFDA has updated import license requirements for investigational medicinal products entering Saudi Arabia. Changes include streamlined documentation for approved CTAs, new cold-chain verification requirements, and updated labeling provisions for Arabic language trial supplies.
FDA Guidance: Use of Real-World Evidence in Regulatory Decision-Making
The FDA has finalized guidance on the use of real-world data and real-world evidence to support regulatory decisions for drugs and biologics. Addresses data quality standards, study design considerations, and appropriate use cases including post-marketing requirements and label expansions.
DoH Reminder: Annual Progress Report Submission Deadline
The UAE DoH reminds all clinical trial sponsors that annual progress reports for active trials are due within 60 days. Reports must be submitted through the electronic portal using the updated template. Late submissions may result in administrative holds on trial activities.
EMA Update: Clinical Trial Information System (CTIS) Enhancement Release
EMA has released a system enhancement update for CTIS, including improved search functionality, new reporting dashboards, automated notification features, and better integration with national competent authority workflows. System downtime scheduled for the migration period.
DoH Guideline: Retention of Clinical Trial Records
The UAE DoH has published a guideline on the minimum retention periods for clinical trial records, aligned with UAE Federal Law requirements. Specifies electronic and paper record retention standards, secure storage provisions, and disposition procedures at end of retention period.
SFDA Notice: Updated Contact Information for Clinical Trial Division
The SFDA has updated contact information for its Clinical Trial Division, including new email addresses, phone numbers, and office hours. A dedicated inquiry line for sponsors with active applications has been established to improve response times.
WHO Global Observatory: Clinical Trial Registration Standards Update
The WHO International Clinical Trials Registry Platform has updated minimum registration dataset requirements. New fields include health condition classification codes, patient-level data sharing plans, and intervention standardization using WHO ATC codes.
ICH M4E(R3): Updated CTD Efficacy Module Guidelines
ICH has published updated Module 5 guidelines for the Common Technical Document efficacy section. Changes include revised statistical study report formatting requirements, updated requirements for clinical overview narratives, and enhanced cross-referencing standards between Module 2 and Module 5.
DoH Draft: Guideline on Decentralized Clinical Trial Elements
The UAE DoH has released a draft guideline for public comment addressing the incorporation of decentralized clinical trial elements including remote consent, home nursing visits, direct-to-patient drug shipment, and telemedicine-based assessments within the UAE regulatory framework.
FDA Workshop Summary: Diversity in Clinical Trials Action Plan
The FDA has published a summary of its recent public workshop on advancing diversity and representation in clinical trials. Key takeaways include enhanced requirements for Diversity Action Plans, community engagement best practices, and anticipated regulatory expectations for enrollment diversity reporting.
SFDA Publishes Approved Clinical Trial Sites Directory
The SFDA has published an updated directory of approved clinical trial sites across Saudi Arabia, including newly accredited facilities in Riyadh, Jeddah, and the Eastern Province. Directory includes site capability classifications and therapeutic area specializations.