Collaboration between the United States and Europe is critical to the success of the global biotech industry. With ongoing policy changes in the EU, companies are assessing any potential impact on their business in the region. This panel will analyze the proposed General Pharmaceutical Legislation (GPL) revisions, including changes to regulatory data protection. Panelists will also discuss the ongoing HTA harmonization process as well as the health data space. This session will review the potential impacts of these policies on the domestic and foreign sectors and avenues to strengthen US-EU collaboration.