Pharmaceutical companies use the MedDRA reference to classify indications, and thus for pharmaco-vigilance for released products. MedDRA provides consistent terminology for medical terms, toxicology issues, medical conditions, and so on. See MedDRA: Medical Dictionary for Regulatory Activities for more information about the dictionary itself and the organizations that maintain it. MedDRA lists the terms that can be used to define indications for a Market Registration submission project, against which a market authorization can be granted. A market authorization is granted for the indication for which the product can be commercialized. Using a MedDRA classification to define an indication allows you to harmonize indication statements for different global regions. Market Registration does not include the MedDRA dictionary. You must subscribe to MedDRA and obtain the zip file that is used to import the dictionary into Market Registration initially or to update the existing dictionary. If you update the dictionary, you can run an Impact Analysis to determine if the classifications you use have been changed, and if so, which submission master records are affected by the change. After you install the MedDRA dictionary, you can use the refinements on the MedDRA Classification Detail View or MedDRA Classification Structure View pages in Market Registration to filter the displayed MedDRA terms. | |||||||