Life Sciences Horizons Brochure 2025 - Flipbook - Page 86
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
Belgium
In Belgium, clinical trials involving investigational
medicinal products containing or consisting of
GMOs are subject to comprehensive regulatory
requirements, as outlined in guidance provided by
the Federal Agency for Medicines and Health Products
(FAMHP) and Sciensano.
Sponsors and investigators must determine the GMO status of
the investigational medical product and identify the appropriate
regulatory path: the "contained use" procedure, the "deliberate
release" procedure, or both. The decision is based on whether
the GMO could be released into the environment and the
associated risks.
For the “contained use” procedure, activities involving GMOs
in controlled environments, such as laboratories or hospital
settings, must follow regional rules (Brussels-Capital, Flanders,
or Wallonia). The sponsor must conduct a risk assessment to
classify the activity (risk classes 1–4) and establish appropriate
containment measures. A biosafety dossier, prepared with input
from a biosafety officer, must be submitted to the regional
competent authority and Sciensano's Service Biosafety and
Biotechnology (SBB). Approval may require updates to the
facility's environmental permit.
If the clinical trial involves a potential GMO release into the
environment, the “deliberate use” procedure applies. This
includes submitting a biosafety dossier, conducting an
environmental risk assessment (ERA), and following additional
public consultation requirements. The FAMHP, in collaboration
with the Biosafety Advisory Council, will evaluate the application.
Most clinical trials involving deliberate use will also require
compliance with contained use regulations.
In addition to the above requirements, the EU CTR procedure
governs the clinical aspects of the trial. The EU CTR dossier must
be submitted via the EU Clinical Trials Information System (CTIS),
and approval from the FAMHP is required before starting the
clinical trial. For GMO-related clinical trials, sponsors are
encouraged to submit both biosafety and clinical trial dossiers
simultaneously to facilitate the process.
Timelines may vary depending on the procedure. Contained use
procedures may typically take 30 days for advice from the SBB,
while deliberate use approvals may take up to 90 days, including
a public consultation period.
Hélène Boland
Senior Associate
Brussels
