The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the contained use framework as far as production, storage, application and inactivation of GMOs used for somatic gene therapy is concerned. In addition, the administration of the product to the clinical trial subject requires an approval underspecial regulations for gene therapy only. According to the Austrian Gene Technology Act (Gentechnikgesetz, GTG), somatic gene therapy aims ata targeted insertion and expression of nucleic acids in somatic cells for the treatment of a hereditary disease or disorder. Investigational medicinal products that contain or consist of GMO but do not fall under the definition of somatic gene therapy do not require a separate authorization for the administration to the clinical trial subjects (e.g. GMO-vaccines).
The applications to seek authorization under the clinical trials framework and under the GMO framework can be submitted in parallel (i.e.the sponsor should apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).
Additional information on the conduct of clinical trials (in German and English) can be found at: https://www.basg.gv.at/en/medicines/prior-to-authorisation/clinical-trials/
Additional information on the application somatic gene therapy can be found at (in German): https://www.bmgf.gv.at/home/Gesundheit/Gentechnik/Fachinformation_Humanmedizin/Somatische_Gentherapie_am_Menschen_zu_medizinischen_Zwecken_-_Informationen_fuer_den_Antragsteller
Application forms to seek authorisation for the GMO aspects
Contained use (production, storage, application and inactivation of GMOs used for somatic gene therapy): https://www.bmgf.gv.at/cms/home/attachments/0/7/0/CH1054/CMS1086176168146/(1)erstmalige_s1_s2.docx
There is no public consultation on GMO aspects prior to granting authorisation.
National authorities involved
Authorization of clinical trials:
Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care)
Traisengasse 5, 1200 Vienna
Authorisation of GMO aspects:
Bundesministerium für Gesundheit und Frauen (Federal Ministry of Health and Women)
Radetzkystraße 2, A-1030 Vienna, Austria
(Last reviewed by the Competent Authority: December 2017)