Life Sciences Horizons Brochure 2025 - Flipbook - Page 88
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
Italy
In Italy, clinical trials involving investigational medicinal
products containing or consisting of GMOs require
authorizations under both the EU CTR and the
GMO legislation.
Sponsors must first assess whether the IMP qualifies as a GMO
under the Italian law and determine whether the clinical trial
falls under the "contained use" (CU) or "deliberate release" (DR)
procedure. If the clinical trials are classified under the contained
use, sponsors must proceed with an assessment to avoid risks to
human health and the environment that the contained use
may cause.
Based on this assessment, sponsors are required to classify
the contained use in one of the risk classes (1-4) listed by the
GMO legislation.
Depending on the chosen risk class, specific notification and
authorization requirements for both premises and activities shall
apply. For example, in case of Class 1 (no or negligible risk), no
notification for the facilities is required if the use takes place in a
facility previously authorised by the Ministry of Health, except in
cases of use within clinical trials with ATMPs that contain or are
composed of GMOs.
Risk classes 2-4 (low to high risk) always trigger the need to notify
both the use and the facility where the use takes place to get the
authorization from the Italian Ministry of Health. Different
notification forms dependent on the risk class are provided for by
the Italian Ministry of Health. The authorization timelines may
vary based on the risk class, but these timelines will not in any
case exceed 90 days.
In addition, if the assessment shows that the medicinal product
contains a GMO that can replicate, transmit, and disseminate into
the environment, an authorization under Part B of the EU
Deliberate Release Directive should also be obtained from the
Italian Ministry for Environment and Energy Security. The overall
timeframe for this authorization is 120 days.
All the authorizations must be issued prior to the beginning of the
clinical trial.
Chiara Perolari
Associate
Milan
