FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS

Their core work

FAMHP is Belgium's national regulatory authority for medicines, medical devices, and health products. Within H2020, they contribute regulatory expertise to European efforts on drug data standardization, pharmacovigilance systems, and cross-border eHealth interoperability. Their role centers on bringing the regulator's perspective to projects that aim to harmonize how medicines are identified, monitored, and governed across EU member states. They also support capacity-building in regulatory science for academia.

What they specialise in

How they've shifted over time

All three of FAMHP's H2020 projects started in 2019, so the early-to-recent evolution reflects thematic breadth rather than a temporal shift. Their earlier-indexed work (EU-STANDS4PM) focused on personalized medicine standards and in silico modelling frameworks, while later-indexed work (UNICOM, STARS) moved toward operational concerns: pharmacovigilance infrastructure, cross-border drug databases, and regulatory science training. This suggests a trajectory from exploratory standardization toward practical regulatory interoperability at European scale.

FAMHP is moving toward operational digital infrastructure for medicines regulation, particularly IDMP-based drug identification and cross-border eHealth — areas that will intensify under EU pharmaceutical reform.

How they like to work

FAMHP participates exclusively as a partner, never as coordinator — consistent with their role as a national authority contributing regulatory expertise rather than driving research agendas. They work in large consortia (67 unique partners across 24 countries from just 3 projects), indicating they join broad European initiatives where regulatory input is needed. This makes them a reliable institutional partner who brings authority and legitimacy but expects others to lead the technical work.

Despite only 3 projects, FAMHP has collaborated with 67 unique partners across 24 countries, reflecting participation in large pan-European consortia. Their network spans most of the EU, with no visible geographic concentration beyond their Belgian base.

What sets them apart

As Belgium's national medicines regulatory authority, FAMHP brings something most research partners cannot: direct regulatory authority and operational knowledge of how medicines are approved, monitored, and governed. For consortium builders, having a national competent authority on board adds credibility with evaluators and ensures project outputs align with real regulatory requirements. They are particularly valuable in projects targeting EU-wide harmonization of drug data or eHealth systems.

Highlights from their portfolio

• UNICOM
  Their largest H2020 investment (EUR 480K) tackling the globally significant challenge of univocal medicines identification using IDMP standards — directly tied to FAMHP's regulatory mandate.
• STARS
  Focused on strengthening regulatory science training in academia, showing FAMHP's commitment to building the next generation of regulatory expertise across Europe.