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
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