Belgium

The Federal Agency for Medicines and Health Products (FAMHP/AFMPS) is the primary regulatory authority in Belgium responsible for ensuring the quality, safety, efficacy, and availability of all health products, including pharmaceuticals, medical devices, in vitro diagnostics, and digital health solutions. The principal legislative framework is grounded in the Law of 25 March 1964 on Medicines, substantially amended over time and complemented by European Union regulations including Regulation (EU) 2017/745 (MDR) for medical devices, Regulation (EU) 2017/746 (IVDR) for in vitro diagnostics, and Directive 2001/83/EC for medicinal products. Belgium operates within the European Medicines Agency (EMA) centralized procedure for many products, while the FAMHP manages national and mutual recognition procedures for others. Approval pathways are determined by product classification, with the FAMHP also playing an active role as a reference or concerned member state in decentralized procedures across the EU.

Applicants seeking market authorization in Belgium must comply with EU-harmonized dossier standards, primarily the Common Technical Document (CTD) format for pharmaceuticals, and must designate an EU-based authorized representative where the manufacturer is located outside the EU. For medical devices and IVDs, conformity assessment through a Notified Body and CE marking are mandatory prerequisites before placing products on the Belgian market, with the FAMHP maintaining the national UDI and device registration database aligned with the European EUDAMED system. Belgium has been proactive in implementing the MDR and IVDR transition timelines and has introduced specific guidance for digital health tools and Software as a Medical Device (SaMD). Recent reforms include enhanced post-market surveillance obligations, strengthened vigilance reporting requirements, and the integration of real-world evidence frameworks into regulatory review processes for innovative health technologies.

Belgium operates a highly structured public procurement system for health products, overseen primarily by the Federal Public Service Health, Food Chain Safety and Environment (FPS Health) and the National Institute for Health and Disability Insurance (NIHDI/RIZIV/INAMI). The NIHDI is the central body responsible for reimbursement decisions, managing separate chapters of the reimbursement list for pharmaceuticals, medical devices, implants, and clinical biology. Procurement at the hospital level is largely decentralized, with individual hospitals and hospital networks conducting their own tenders in accordance with the Belgian Public Procurement Law of 17 June 2016, which transposes EU Directive 2014/24/EU. Purchasing consortia and hospital networks play an increasingly influential role, leveraging collective bargaining to negotiate pricing. The federal government also intervenes directly through framework agreements for specific product categories, including vaccines and certain strategic health commodities, coordinated through the FAMHP and FPS Health.

The private sector in Belgium is well-developed, with a significant share of health products distributed through pharmacy chains, specialist distributors, and private hospital networks operating under regulated pricing and margin frameworks. Belgium does not rely substantially on donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, Gavi, or USAID, given its status as a high-income country with a comprehensive social security system. However, Belgian institutions and research centers are active participants in EU joint procurement mechanisms, including the Joint Action on Health Security and the EU Health Emergency Preparedness and Response Authority (HERA) frameworks established following the COVID-19 pandemic. There are no formal local manufacturing preference policies mandating domestic sourcing; however, Belgium hosts a significant pharmaceutical and medical technology manufacturing base, and government innovation policies such as those coordinated through the Belgian Health Care Knowledge Centre (KCE) increasingly consider health technology assessment (HTA) outcomes and local value contribution in shaping reimbursement and procurement decisions.