Ebling Library users now have access to the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA “has been developed as a pragmatic, clinically validated medical terminology with an emphasis on ease-of-use data entry, retrieval, analysis, and display, with a suitable balance between sensitivity and specificity, within the regulatory environment. MedDRA is applicable to all phases of drug development and the health effects of devices. By providing one source of medical terminology, MedDRA improves the effectiveness and transparency of medical product regulation worldwide.” MedDRA is the clinically-validated international medical terminology that is being implemented by the U.S. Food and Drug Administration (FDA) as well as by the regulatory authorities in the European Union (EMEA) and the Japanese Ministry of Health and Welfare (MHW). MedDRA is applicable to all phases of drug development and the health effects of devices.
In order to use MedDRA, users need to download data files, dowload and install the MedDRA Browser, and then import the data files into the MedDRA browser. Detailed instructions are available for our users, including the required login information.