This chapter explores the transformative impact of artificial intelligence (AI) on drug discovery and development, highlighting its potential to accelerate timelines, reduce costs, and enhance precision. However, the integration of AI introduces significant regulatory, ethical, and data challenges. Key issues include safeguarding patient privacy, addressing cybersecurity threats, ensuring explainability of AI models, and navigating evolving regulatory frameworks. The chapter examines strategies for advancing data protection, fostering industry-academic collaborations, and promoting standardization to ensure interoperability and data quality. It emphasizes the importance of transparency, ethical governance, and international harmonization to build trust and enable equitable access to AI-driven innovations. By addressing these challenges, the pharmaceutical sector can responsibly harness AI’s potential to deliver safe, effective, and accessible medicines.