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Why Belgium and Flanders are a home base for clinical trials

In Belgium, of which Flanders is the northern region, there are currently some 20 clinical trials ongoing in hospitals to test the safety and efficiency of COVID-19 candidate vaccines and medicines. This only adds to previous studies, facts and figures on the country’s and region’s position as a major European pharma development and production valley as well as a leading biopharma innovation hub. A recent newsletter by sector federation pharma.be shines more light on the state of early-stage clinical trials in Belgium.

Clinical trials in Flanders and Belgium

Major center of expertise

“Overall, Belgium has the highest number of clinical trials per capita in Europe, after Denmark and Estonia,” explains Nathalie Lambot, specialist in clinical trials at pharma.be. “In 2019 alone, there were as many as 526. The local pharmaceutical environment is very attractive, not only because of the high quality level of the authority issuing the necessary licenses – the Federal Agency for Medicinal Products –, but also because of the quality of the local hospitals, clinical research centers and doctors, who have years of experience under their belts.”

In particular, as Lambot further points out, Belgium and Flanders as a region are highly regarded when it comes to phase 1 clinical trials. This is mainly due to the Belgian ecosystem for such clinical trials, which consists of “7 university hospitals, 12 universities with life sciences departments and internationally renowned research teams, 14 bioincubators and 52 companies active in clinical R&D.”  

“What’s more,” Lambot continues, “Belgium is home to progressive companies and excellent research centers in therapeutic fields such as oncology, vaccination as well as gene and cell therapy. Across the country, there are 8 units specialized in phase 1 clinical trials, conducting studies on healthy volunteers. But there are also many hospital departments that offer the possibility to carry out phase 1 studies with volunteering patients.” In the future, this top-class life sciences ecosystem is bound to get another boost with the launch of Europe’s first-ever vaccinopolis in Flanders.

Speed advantage

Another contributing factor is the favorable regulatory framework in Belgium and Flanders as a region, which comes with a shorter deadline for the approval of phase 1 clinical trials by the competent authorities and local ethics committee.

“With just 15 days for phase 1 trials, Belgium has one of the shortest approval periods for early-stage studies in Europe,” Lambot continues. “Thanks to a federal law on clinical trials of medicinal products for human use, which was approved on 7 May 2017, this speed advantage will be maintained even when the European Clinical Trials Regulation is introduced for studies initiated in Belgium and Flanders.”

The proof is in the figures: a European comparison

According to pharma.be, in 2018, 25.6% of the clinical trials authorized in Belgium and Flanders as a region were phase 1 studies, compared to 22.1% on average across the European Union. What’s more, in that same year, 43 initial human studies were admitted, representing 8.2% of the total number of studies admitted in 2018, which is also a higher percentage than in other EU member states.

About Belgium and Flanders

With Dutch as its official language, Flanders (Dutch: Vlaanderen) is the autonomous northern region of Belgium. The capital of both Belgium and Flanders is Brussels.

More info

pharma.be
Reported by
pharma.be website
4 November 2020

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