Clinical trial applications for investigational medicinal products that contain or consist of genetically modified organisms: industry experiences under the European Union Clinical Trial Regulation (536/2014)

The survey reported upon here provides an up to date understanding of industry experiences submitting national GMO applications since the CTR has been in application (January 31, 2022). The survey shows how time- and resource-intensive applications seeking authorizations for use of investigational medicinal products that contain or consist of genetically modified organisms (GMO-IMPs) to EU Member States continue to represent a significant challenge for developers. EU Member State GMO competent authorities presently apply differing interpretations of the European Commission Directives for Deliberate Release of GMOs and/or the Contained Use of GMOs. Survey feedback highlights how varied the different EU Member State GMO competent authority procedures and assessment timeframes are, with differences in adaptation to the timelines dictated by the Clinical Trial Regulation (CTR). Lengthy and uncertain timelines associated with EU Member State GMO competent authority procedures were indicated to have led sponsors to have looked to other regions (USA, Canada, and Australia) to host clinical trials with GMO-IMPs. The benefits of a single clinical trial application submission under the CTR are considerably diminished due to different national GMO procedural and documentation requirements and a lack of formal alignment of timelines between CTA and GMO procedures. EFPIA welcome the proposed improvements for regulation of GMO medicines through revision of the EU General Pharmaceutical Legislation.

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