Covington Germany Life Sciences Update – Spotlight: Clinical Trials

The Covington team shared updates on the latest legislative and regulatory developments for Clinical Trials with Pharmaceuticals in Germany. Several of these are also relevant for Clinical Trials with Medical Devices.

Topics covered included:

• The new “Standard Contract Clauses” for clinical trial agreements and practical implications (applicable from 17th December 2025)
• New criteria for delineating clinical trials from non-interventional-studies – chances and risks for sponsors
• Special issues in studies using diagnostic assays & Companion Diagnostics (CDx)
• Data Protection issues and practical recommendations
• Enforcement and GCP inspection trends
• Market access (pricing & reimbursement) benefits when clinical trials are conducted in Germany