Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the authorisation procedure for research into gene therapy or a medicinal product containing a genetically modified organism (GMO), that is aimed at combating COVID-19.
Clinical research into gene therapy or a medicinal product containing a GMO requires a license from the Ministry of IenW. The Ministry of IenW has now set up an emergency regulation (in Dutch) accelerating the procedure of granting a license and enabling investigators to start clinical trials with such products earlier. The emergency regulation has been published in the Staatscourant (Government Gazette) and has been in effect since March 31.
The time limit on the application will be shortened to a maximum of 28 days. This regulation does not make any concessions to safety in working with GMOs. The regulation only applies to permit applications for research aimed at the preventive or curative control of the pandemic of COVID-19.