Presently, EU Member State GMO competent authorities apply differing interpretations of the EC Directives for Deliberate Release and/or the Contained Use of GMOs. An industry survey shows how time- and resource-intensive applications seeking authorisations for use of GMO Investigational Medicinal Products to Member States continue to represent a significant hurdle for developers. 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 CTR. This has led to delays to the initiation of clinical trials, especially within the two countries that currently require that the GMO submission be approved prior to submission of the CTA. There is currently no mechanism for a single submission and coordinated evaluation of GMO applications for multinational trials. 
Through the EC’s reform of the EU General Pharmaceutical Legislation, instead of needing to submit GMO dossiers to GMO Competent Authorities for each country where it is intended to perform a clinical trial, the EC proposes harmonisation through a centralised, single Union procedure, to be conducted in parallel to a CTA. The EMA CHMP shall assess the GMO submission (that includes an Environmental Risk Assessment (ERA) in the form of a scientific opinion, for both clinical trials and MAAs. The ERA will be tailored to the requirements for investigational medicinal products (instead of GMO plants). The GMO requirements will follow principles similar to that of the Deliberate Release Directive. The Contained Use Directive will no longer be applicable and there will be no national notification requirements under this Directive. April 2024, the European Parliament voted to adopt the proposals with amendments that introduce a risk-based approach. This includes the non-requirement for an ERA of investigational medicines with demonstrated low environmental risk, prior to a clinical trial.

CTAs for Investigational Medicinal Products that Contain or Consist of GMOs: Industry Experiences under the EU Clinical Trial Regulation

Collaborating for Healthcare Innovation – a focus on Sustainability!

18-20 March 2025
Basel, Switzerland

DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.

Join us in the vibrant city of Basel for an unforgettable experience, where the power of collaboration will be on full display to inspire actionable outcomes and mobilise for solutions the life sciences’ community. Witness first-hand the profound impact of united efforts, gain valuable insights from across the drug development lifecycle, and play an active role in shaping the future of the pharmaceutical arena.

DIA Europe 2025

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.