Tag archive

Regulatory Change

publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Aug 14, 2026

Mandatory Submission of Briefing Documents for Scientific Advice Requests

PV teams must prepare and finalize safety-related briefing materials, including risk management plans and protocols, for initial submission by September 2026.

Country ComplianceSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Guidance / Process Change

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publicFDA · United States · Updated Aug 3, 2026

Modification of Certain Terminology in Title 21; Reopening of the Comment Period

Urgency: High

MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.

ICSRCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Consultation

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