Clinical trials with genetically modified medicinal products

Since 1 October 2022, all Summary Notification Information Format documents submitted with applications for clinical trials with medicinal products, entirely or partly composed of genetically modified organisms covered by Directive 2001/18/EC for deliberate release, must be submitted through the E-Submission Food Chain platform.

E-Submission Food Chain platform
The European Commission developed the E-Submission Food Chain (ESFC) platform to publish Summary Notification Information Format (SNIF) documents for activities covered by Directive 2001/18/EC (part B) for the deliberate release of genetically modified organisms (GMOs) into the environment. The platform will thus allow sponsors to submit and follow-up their SNIF documents online.

From 1 October 2022, sponsors will be required to submit SNIF documents for new clinical trial applications through the ESFC platform.

More information on the ESFC procedure and video user guides are available on the European Commission website. The ESFC user guide (pages 81-83/149) also contains instructions on how to submit the SNIF document through the platform.

Submitting clinical trials according to Directive 2001/20/EC (until 30 January 2023)
The entire initial application for clinical trials according to Directive 2001/20/EC can still be submitted via the Common European Submission Portal (CESP), to the Research and Development Division of the Federal Agency for Medicines and Health Products (FAMHP), as indicated in our guidance document, until 30 January 2023. This clinical trial application should also include the biosafety dossier and the SNIF document. More information on GMO aspects is available in the GMO guidelines.

Sponsors will be asked to separately submit the SNIF document through the ESFC platform when the biosafety dossier is considered complete after validation and a biosafety T0 has been provided.

Submitting clinical trials according to European Regulation 536/2014
An application for a clinical trial according to Regulation 536/2014 must be submitted via the Clinical Trials Information System (CTIS). Important note: the biosafety dossier cannot be submitted via CTIS and must therefore be submitted in parallel via CESP to the FAMHP Research and Development Division. Please clearly indicate the link between the two dossiers in the cover letters.

Sponsors will be asked to separately submit the SNIF document through the ESFC platform when the biosafety dossier is considered complete after validation and a biosafety T0 has been provided.

Questions?
European Commission contact page

Last updated on 19/01/2023