Jurisdiction

Belgium

Regulation Category Type · Breadth Date

BioVigilance web application launched for reporting adverse events related to substances of human origin

FAMHP launches BioVigilance, an online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin intended for human application.

FAMHP (Belgian Medicine Agency) · Belgium

Health Data, Privacy & SecurityGeneral Regulatory Health data Cybersecurity

Administrative Framework Aug 03, 2026

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Future European legislation: state of play

FAMHP updates on pending EU legislative initiatives including the Biotech Act, MDR/IVDR revision, Critical Medicines Act, pharmaceutical legislation and online health information measures.

FAMHP (Belgian Medicine Agency) · Belgium

PharmaceuticalsMedical Devices & IVDDigital Health & AI Medical devices Pharmaceuticals Digital therapeutics

News & press Framework Jul 07, 2026

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