Tag archive

inspection

publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Aug 18, 2026

UK Position Paper on Microbiome-Based Medicinal Products (MBMPs)

MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: Position Paper

Read impact briefarrow_forward

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

Read impact briefarrow_forward

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

Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only