Abstract

The integration of artificial intelligence (AI) in drug discovery and development has revolutionized the pharmaceutical industry, offering unprecedented opportunities for accelerating the identification of novel therapeutics. However, the rapid advancement of AI-generated drugs necessitates robust regulatory frameworks to ensure safety, efficacy, and ethical considerations. This article provides a comprehensive analysis of the regulatory landscape governing AI-generated drugs, exploring the challenges, opportunities, and future directions. The discussion encompasses the current regulatory environment, the role of international regulatory bodies, the ethical implications, and the need for adaptive regulatory frameworks. The article concludes with recommendations for harmonizing global regulations to foster innovation while safeguarding public health.