Tag archive

policy-change

publicSaudi Food and Drug Authority (SFDA) · Saudi Arabia · Updated Jun 28, 2026

Regulations and Requirements for Conducting Clinical Trials on Drugs (Version 4.0)

Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact3 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead, QPPV

verifiedRegulatory action: Regulation

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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 29, 2026

Use of AI in GXP Inspection Responses

Urgency: High

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

Inspection ReadinessCAPARegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead

verifiedRegulatory action: Guidance / Notice

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publicSwissmedic (Swiss Agency for Therapeutic Products) · Switzerland · Updated Jun 22, 2026

Adoption of ICH E6(R3) Annex 2 for Good Clinical Practice

Urgency: High

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Inspection ReadinessCAPARegulatory Intelligence Lead

SOP Impact3 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead

verifiedRegulatory action: Notice

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publicDanish Medicines Agency · Denmark · Updated Jun 25, 2026

IB template for cell therapy products

Urgency: High

Utilize the IB template provided for cell therapy products in clinical trial applications, available under the 'Special Product Areas' section of the Danish Medicines Agency's website.

Inspection ReadinessRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead

verifiedRegulatory action: Template

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