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firecrawl-policy-agent

publicFDA · United States · Updated Jun 12, 2026

FDA Study Data Technical Conformance Guide Update

Urgency: High

Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Technical Guidance
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publicEuropean Medicines Agency · European Union · Updated Jun 12, 2026

Introduction of Mandatory Annual Safety Report (ASR) Module in CTIS

Urgency: High

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
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publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 12, 2026

Product Management Service (PMS) public API beta release - Technical registration requirements

Urgency: High

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Country ComplianceICSRRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Technical Guidance
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