Life Sciences Horizons Brochure 2025 - Flipbook - Page 90
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
Spain
In Spain, clinical trials involving investigational
medicinal products containing or consisting of GMOs
are understood as deliberate release activities and, as
such, require authorization under the EU CTR and
the GMO-legislation. Although both applicationauthorization procedures are separate from each
other, it is standard practice to process both
procedures in parallel.
For the purpose of the deliberate release authorization, the
following authorities stand out:
the Inter-ministerial Council on Genetically Modified
Organisms ("CIOMG"), attached to the Ministry of Agriculture,
Fisheries and Food ("MAPA"), as the body responsible for
granting the authorization, and
the National Biosafety Commission ("CNB"), attached to the
Ministry for Ecological Transition and Demographic Challenge
("MITECO"), as the technical-scientific body responsible for
the mandatory reporting in the context of the applicationauthorization procedure.
The CNB has issued a technical guide that details the deliberate
release application-authorization procedure (generally, only one
application per sponsor and clinical trial is required), as well as the
documents to be attached to the application. It also includes
detailed information about the application-authorization
procedure for clinical trials involving specific GMOs (e.g.,
genetically modified human cells, viral vectors, or AAV vectors).
The (standard) application-authorization procedure takes the
following steps:
request for the notification number;
online filing and submission of the application (form) and
additional documents (technical dossier, SNIF, conclusions on
the specific areas of risk of the ERA, and other documentation,
where applicable) through this link;
public consultation (30 days) of the application summary;
risk assessment report by the CNB; and
decision by the CIOMG within 90 days from the receipt of
the application.
Interestingly, both the risk assessment reports by the CNB and the
decisions on the application by the CIOMG are published on the
MAPA's website here and here.
Álvaro Abad
Senior Associate
Madrid
