Tag archive

Technical Guidance

publicFDA · United States · Updated Jun 12, 2026

FDA Study Data Technical Conformance Guide Update

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 (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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publicEuropean Medicines Agency · EU · Updated Jul 15, 2026

Updated eCTD v4.0 technical validation criteria

Urgency: High

All electronic PV submissions must undergo new validation checks in accordance with the updated criteria to ensure compliance and accuracy.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Technical Guidance

Read impact briefarrow_forward

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