Belgium, located in Western Europe, is a small yet culturally rich and strategically significant country. Belgium's healthcare sector is characterized by a well-established and comprehensive system that prioritizes accessibility and quality of care.
The country boasts a universal healthcare system, ensuring that all residents have equal access to medical services. The government plays a significant role in regulating and financing healthcare, working in collaboration with various health insurance funds.
Belgium's pharmaceutical market is set to grow steadily at 4.35% from 2022 to 2027. As per statista, revenue is expected to show an annual growth rate of 6.00% (CAGR 2024-2028) , resulting in a market volume of US$7.02 bn by 2028.
Belgium is home to several leading pharmaceutical manufacturing companies that contribute significantly to the global healthcare market.
Major players like, AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, UCB and GlaxoSmithKline dominate the competitive landscape, engaging in strategic acquisitions.
Notably, the cardiovascular and oncology segment is expected to witness significant growth due to lifestyle changes, regulatory approvals, scientific advancements, and increased awareness of heart health.
In addition to the Federal Agency for Medicines and Health Products (FAMHP), Belgium collaborates with the European Medicines Agency (EMA) to ensure harmonized regulatory standards across the European Union.
Authorization of Medicines
All medicines must be authorized before they can be marketed and made available to patients.
In the EU, there are two main routes for authorizing medicines: a centralized route and a national route. The data requirements and standards governing the authorization of medicines are the same in the EU, irrespective of the authorization route.
In the centralized authorization process, pharmaceutical companies submit a single application to the European Medicines Agency (EMA) for approval to market a medicine across the European Union (EU).
The EMA's Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) conducts a scientific assessment and recommends whether the medicine should be marketed.
Each EU Member State has a representative in CHMP, acting as intermediaries between European and national systems.
The CHMP appoints two rapporteurs for each drug, overseeing its entire life cycle. The evaluation takes a maximum of 210 days, with possible interruptions for firm responses or oral explanations. The final "Opinion" is sent to the European Commission for a decision.
Upon a positive decision, the Summary of Product Characteristics and package leaflet are established, and a European Public Assessment Report is published on the EMA website.
Post-approval, the applicant receives European market authorization valid in all EU and EEA Member States.
The centralized procedure is mandatory for medicines treating specific conditions like HIV, cancer, and rare diseases, as well as for biotechnology-derived medicines and certain veterinary products.
It is optional for other medicines with new substances or significant innovations, provided authorization is in the interest of EU-wide public or animal health.
In the national authorization process, the Marketing Authorization (MA) application is submitted to the Federal Agency for Medicines and Health Products (FAMHP) in Belgium.
The Commission for Medicinal Products for Human Use (CMH) within the FAMHP appoints case evaluators.
Their report is then reviewed by the Committee on Medicinal Products for Human Use. The CMH advises on marketing authorization and scientific aspects related to medicines.
The Commission assesses a drug's benefit/risk balance based on efficacy, safety, and quality. Following the assessment, the Minister or delegate issues a decision to the applicant.
A positive evaluation results in the applicant receiving a national MA with a unique identifier.
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