Call for overhaul of EU rules on GMO clinical trial

Four organisations representing pharmaceutical firms, biotech companies, universities, and research institutes are calling on the European commission to update, streamline and standardise regulations used to assess applications for clinical trials of new therapies using genetically modified organisms (GMOs), saying that the current process is outdated and cumbersome.

In a joint position paper, the organisations say sponsors applying to conduct GMO clinical trials now face complicated regulatory disparities at the national level that slow down the process. The position paper recommends 11 possible solutions for improving and harmonising the framework, adding that an update would boost Europe’s biomedical sector and help ‘avoid unnecessary delays in patient access’ to innovative medicines consisting of or containing GMOs – for example gene or cell-based therapies.