The Moving Regulatory Landscape For Gene Therapy Trials In EU: Part 2

The Clinical Trial Regulation No. 536/2014 (CTR) harmonizes clinical trial submissions in the EU, including those for Gene Therapy Medicinal Products (GTMPs). However, environmental requirements for GTMPs containing GMOs are not fully covered by the CTR. Such trials require compliance with EU Directives, varying by Member State.

The GMO application for a clinical trial includes a Summary Notification Information Format (SNIF) form. Previously, the SNIF was submitted with other GMO documents to the Competent Authority (CA) of the involved Member States. As of October 2022, the SNIF must be submitted separately through the E-Submission Food Chain (ESFC) platform.

The SNIF is a public summary of the GMO release, required by Directive (2001/18/EC). The Transparency Regulation (EU/2019/1381) adjusted the SNIF submission process. While the GMO application remains with the CA, the SNIF is sent directly to the European Commission (EC) via ESFC. The CA then assesses the SNIF within the platform.

The ESFC platform submission process has its complexities. The SNIF cannot be prepared offline and must be populated within the platform. Additionally, the submission order varies between Member States. Amendments to the CTA affecting the SNIF also require specific handling.

ProPharma offers expertise in navigating the SNIF submission process and understanding the intricacies of GMO requirements for clinical trials with GTMPs. Learn how they can provide support with application preparation, submission, and management across required territories by accessing the full article below.