HC Guidelines for Radiopharmaceutical Submissions – A Regulatory Synopsis
Radiopharmaceuticals are pharmaceutical drugs that contain radioisotopes, which are used as diagnostic and therapeutic agents. They target specific organs, tissues, or cells in the human body. These medicinal products can be delivered orally, intravenously, or interstitially, and they form a subspecialty of radiation therapy. There are strict regulations for marketing radiopharmaceuticals, as they can be administered only by a professional specializing in nuclear medicine.