Issues on the Reporting Obligations of the Serious Adverse Reaction of the Experimental Research of New Medicament
The purpose of this article was to discuss the obligation to report the serious adverse event (SAE) or serious adverse reaction (SAR) and related legal issues on the experimental research of new medical technology, new medicament, and new medical implement. First, the definition and bulletin of the SAE or SAR of the experimental research of new medicament are discussed by using the Regulations for Good Clinical Practice (GCP). Then, the differences and confused concepts of the bulletin of the experimental research of new medical technology and new medical implement are compared with those of the bulletin of the experimental research of new medicament. Finally, we provide suggestions for the obligation to report the expected serious adverse reaction and unexpected serious adverse event on the experimental research of new medicament based on the viewpoints of the protection of the human research participants and the interpretations of the law.