The initiation of a clinical trial with an investigational medicinal product that consists of or contains a GMO is currently a lengthy and complex process in Europe due to the fragmentation of GMO application procedures and data requirements implemented by each EU Member State. Moreover, this fragmented landscape for GMO applications poses challenges when sponsors attempt to coordinate with clinical trial applications and their harmonisation under the European Clinical Trials Regulation to be implemented January 2022.
The platform to submit Clinical Trial Applications, the Clinical Trial Information System (CTIS), lacks the functionality to receive national GMO Competent Authority documents, including the Environmental Risk Assessment, EU Common Application Form(s) and other possible national forms. Since GMO submissions to national GMO competent authorities are not coordinated with Clinical Trial Applications submitted via the CTIS, sponsors of clinical trials cannot leverage the advantage of the single dossier submission of the Clinical Trial Application and synchronous approval across those EU member states to initiate the clinical trial across the intended countries. Different EU Member State GMO Competent Authorities implement different GMO submission timelines, which has led to delays to the start to clinical trials of GMO medicine products.
Due to future challenges to obtain a parallel approval of a GMO submission and a clinical trial application under the Clinical Trial Regulation, Europe could be perceived to be less attractive to sponsors. Other regions have less stringent GMO requirements – for example the United States, since 2015, have adopted a “categorical exclusion” for investigational (GMO-) advanced therapeutics and vaccines.
These EFPIA-authored findings and considerations were published in Cell & Gene Therapy Insights on the 30th September 2021.
Further to our call earlier this year in May, suggesting that the EC adapts its legislation to embrace advances in science, technology and medicines, Pär Tellner, Director of Regulatory Affairs at EFPIA, stated how “EFPIA reiterates its call for a permanent exemption from GMO requirements for ATMPs containing or consisting of GMOs, as well as for vaccines, to accelerate European patients’ access to these potentially life-saving medicines. However, in the meantime, a pragmatic and simplified approach for the GMO assessment should be considered by each EU Member State, ideally with solutions towards greater harmonisation to the clinical trial application.”