Photocarcinoma is a type of skin cancer that develops due to long-term exposure to ultraviolet (UV) radiation. It includes various kinds of UV-related skin cancer, such as melanoma, basal cell carcinoma, and squamous cell carcinoma, which are major health challenges in the world today because of their increasing prevalence. This chapter in this book talks about the clinical and regulatory infrastructure underpinning the development of photocarcinoma drugs and therapies. The Introduction provides a summary of the worldwide effects of photocarcinoma, highlighting the importance of clinical and regulatory approaches to addressing this health issue. Further in later part of this book chapter it signifies the various phases of clinical trials exclusively to treat photocarcinoma. In the third section, the regulatory approval pathways of the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are examined, and a comparison is made. The issue of ethical dilemma—such as those regarding patient consent and openness—is crucial to consider when conducting clinical trials for the development of therapies. The fourth section is critical as it discusses the significance of safety monitoring and Phase IV clinical studies and examines adverse event reporting, risk mitigation strategies, and recent safety issues. Lastly, this chapter looks forward to future trends in clinical and regulatory practices and guidelines, including the integration of artificial intelligence, nanotechnology, and personalized medicine. Such discoveries pave the way for more efficient and focused treatments and better patient outcomes in the management of photocarcinoma.