Federal Agency for Medicines and Health Products

What Federal Agency for Medicines and Health Products does

The Federal Agency for Medicines and Health Products (AFMPS / Agence fédérale des médicaments et des produits de santé) is the Belgian federal competent authority responsible for ensuring the quality, safety, and efficacy of medicines and health products in Belgium. The agency, headquartered in Brussels and operating as a state entity under the Belgian Federal Government, regulates human and veterinary medicinal products, medical devices, blood products, and human tissue materials, and represents Belgium in EU-level regulatory coordination with EMA and the European Commission.

AFMPS operates a portfolio of digital regulatory platforms including the Medicine Database, the Suspended Medicines Database, EUDAMED for medical device registration (mandatory from May 28, 2026), the Clinical Trials Information System (CTIS) with a Belgian dashboard, the PharmaStatut availability portal, and a recently launched VAMREG application for recording veterinary antibiotic transactions. It also runs pharmacovigilance, material vigilance, hemovigilance, and biovigilance reporting systems covering adverse drug reactions, medication errors, quality defects, medical device incidents, and blood or tissue-related events.

The agency serves three primary stakeholder groups: the general public (medicine information, adverse-effect reporting, availability data), the pharmaceutical industry and healthcare professionals (marketing authorizations, clinical trial oversight, pharmacovigilance compliance), and clinical trial sponsors and researchers (trial authorization and CTIS submissions). As a federal regulatory authority, AFMPS does not sell products or services and has no commercial revenue model; all activities are publicly funded and operated through official channels including its multilingual website, public consultations, and social media presence.

Name

Federal Agency for Medicines and Health Products

Legal name

Agence fédérale des médicaments et des produits de santé

Website

https://fagg-afmps.be

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

251–500 employees

Short description

The Belgian federal regulatory authority ensuring the quality, safety, and efficacy of medicines and health products. It operates digital platforms for medicine authorization, pharmacovigilance, clinical trial oversight, and medical device regulation within the EU framework.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Health Product Regulation

NAICS

Public Administration (92)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Medical Device Regulators (HLAJADAC), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

Keywords

• Pharmaceutical regulatory services
• Medicine marketing authorization
• Pharmacovigilance monitoring
• Clinical trial oversight
• Medical device regulation

Headquarters

HQ city

Saint-josse-ten-noode

HQ country

Belgium

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Others

Distribution channels2 records

Marketing channels4 records

Core offering

The Federal Agency for Medicines and Health Products (AFMPS) is the Belgian federal regulatory authority responsible for ensuring the quality, safety, and efficacy of medicines and health products in Belgium. It grants marketing authorizations for human and veterinary medicines, oversees clinical trials, manages the Belgian Medicine Database, monitors pharmacovigilance and adverse event reporting, implements EUDAMED for medical devices, and operates reporting portals (VAMREG, PharmaStatut) for regulated entities and the general public.

Product overview

The Federal Agency for Medicines and Health Products (AFMPS/FAVV) operates as Belgium's national regulatory authority for medicines and health products. The agency provides a portfolio of digital platforms and regulatory services including the VAMREG veterinary antibiotic recording system, the Medicine Database for authorized medicines information, EUDAMED for medical device registration, CTIS for clinical trials oversight, and PharmaStatut for medication availability tracking. Additionally, the agency operates pharmacovigilance, material vigilance, hemovigilance, and biovigilance reporting systems for adverse event monitoring across medicines, medical devices, blood products, and human tissues.

Differentiator

Problem solved

Functional benefit

Products and services

• VAMREG (Veterinary Antibiotic Recording Application) An online application that enables veterinarians and pharmacists holding a deposit to register and track veterinary antibiotic transactions as part of antimicrobial resistance monitoring in Belgium.
• Medicine Database (Base de données des médicaments) Public database providing information on authorized medicines for human and veterinary use, including package leaflets (notices), Summary of Product Characteristics (RCP), RMA, DHPC and s-RMP information for the Belgian public and professionals.
• EUDAMED (European Database on Medical Devices) European medical devices database used by AFMPS for the registration and tracking of medical devices in Belgium, with mandatory module use from May 28, 2026 in compliance with the European Commission.
• CTIS (Clinical Trials Information System) with Belgian dashboard European clinical trials database enabling search and registration of clinical trials in Belgium, with a Belgian national dashboard for oversight and integration with the European CTIS system.
• PharmaStatut Web portal that provides information on the availability status of medicines in Belgium and allows notification of changes to a medicine's marketing authorization status (marketed or no longer marketed).
• Pharmacovigilance Reporting System System enabling reporting of adverse drug reactions, abuse, medication errors, and quality defects for human and veterinary medicines, used by healthcare professionals and the general public.
• Material Vigilance System System for reporting incidents and adverse events related to medical devices and their accessories in Belgium.
• Hemovigilance System System for reporting incidents related to blood or blood products in Belgium.
• Biovigilance System System for reporting incidents related to human bodily materials, including tissues and cells, in Belgium.
• AFMPS Secure Web Portal (Portail web) Secure web portal used by regulated entities (manufacturers, sponsors, healthcare professionals) to access AFMPS services and submit regulatory information to the agency.

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• SMEMDN Consortium (European Medical Device Nomenclature Consortium)coreStrategic or Co-development Partner · 4 June 2026The SMEMDN consortium is organizing training on the European nomenclature for medical devices. AFMPS invites manufacturers and stakeholders to participate in this training on June 4, 2026, supporting the implementation of EUDAMED requirements.
• SPF Santé Publique (Federal Public Service Health)coreStrategic or Co-development PartnerJoint public consultation with SPF Santé publique on gene-modified medicines clinical trials, specifically for ATSN-201 treatment for retinoschisis, demonstrating inter-agency collaboration on advanced therapy medicinal products.
• PharmaInfo.beminorOthersPharmaInfo.be is referenced as a partner resource on the AFMPS website for public information about medicines and health products.
• European Medicines Agency (EMA)coreStrategic or Co-development PartnerAFMPS participates in EU-level regulatory coordination through EMA, contributing to European marketing authorization application predictability and regulatory harmonization across member states.
• European Commission (EUDAMED)coreStrategic or Co-development PartnerAFMPS implements EUDAMED, the European database for medical devices, with mandatory use of first modules from May 28, 2026, in compliance with European Commission requirements.
• EDQM (European Directorate for the Quality of Medicines)coreStrategic or Co-development PartnerAFMPS aligns with EDQM best practices for pharmaceutical barcode requirements on primary packaging for hospital medicine traceability, addressing Falsified Medicines Directive gaps.

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• European Medicines Agency (EMA): EMA is the EU-level medicines regulator coordinating marketing authorizations, pharmacovigilance, and clinical trial oversight across member states. It is comparable to AFMPS as a regulator of human and veterinary medicines but operates at a pan-European scale, making AFMPS a national-level implementation and coordination counterpart.
• U.S. Food and Drug Administration (FDA): The FDA is the United States' federal medicines, biologics, medical devices, and food regulatory authority. It performs the same core functions as AFMPS—authorization, pharmacovigilance, clinical trial oversight—at a much larger global scale, serving as the benchmark reference for national regulators.

Regional players

• Federal Institute for Drugs and Medical Devices (BfArM): BfArM is Germany's federal regulator for medicines and medical devices, with responsibilities closely mirroring AFMPS including marketing authorization, pharmacovigilance, and clinical trial oversight. It is comparable in mandate and portfolio but serves the German market rather than Belgium.
• Agence nationale de sécurité du médicament (ANSM): ANSM is France's national medicines and health products safety agency. It performs the same statutory functions as AFMPS—authorization, vigilance, and medical device oversight—serving the French market with similar EU integration.
• Agenzia Italiana del Farmaco (AIFA): AIFA is Italy's national medicines authority responsible for marketing authorization, pharmacovigilance, and pricing/reimbursement oversight. Comparable to AFMPS in core regulatory mandate, serving the Italian market within the EU framework.
• Medicines Evaluation Board (MEB / CBG): The Dutch MEB is the Netherlands' medicines evaluation authority handling marketing authorization and pharmacovigilance. Directly comparable in role and EU integration to AFMPS, serving the Dutch market.
• Medicines and Healthcare products Regulatory Agency (MHRA): MHRA is the UK's medicines and medical devices regulator post-Brexit, performing marketing authorization, pharmacovigilance, and medical device oversight. Functionally analogous to AFMPS but serving the UK market with its own post-EU regulatory regime.
• Swissmedic: Swissmedic is Switzerland's national medicines and medical devices authority. Comparable to AFMPS in mandate—authorization, vigilance, clinical trial oversight—operating outside the EU but with bilateral recognition agreements.
• Spanish Agency of Medicines and Medical Devices (AEMPS): AEMPS is Spain's national medicines and medical devices regulator with a mandate closely aligned to AFMPS, including marketing authorization, pharmacovigilance, and EUDAMED-aligned medical device oversight for the Spanish market.
• Therapeutic Goods Administration (TGA): TGA is Australia's national medicines and medical devices regulator. Functionally comparable to AFMPS with respect to authorization, pharmacovigilance, and clinical trial oversight, but serving the Australian market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@federalagencyformedicines
• Facebookfacebook.com/AFMPS.be
• LinkedInlinkedin.com/company/808980
• Instagraminstagram.com/afmps_be

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Federal Agency for Medicines and Health Products