Medical Coding Dictionaries
MedDRA:
The Medical Dictionary for Regulatory Activities (MedDRA) contains medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines). Coding this data to a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products. The FDA currently uses MedDRA in several of its internal data systems.
MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), acting as trustee for the ICH steering committee.
The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA. The MSSO is the source for the most up-to-date information regarding MedDRA and its application.
MedDRA updates are released Bi-Annually (1 March and 1 September) by the MSSO.
WHO Drug:
The World Health Organization's Drug Dictionary (WHO DD) is a comprehensive source of medicinal product information used to identify drug names, active ingredients, and therapeutic use in the course of drug safety surveillance. It translates a drug name into useful information, which is used for coding and analysis of drug safety data, for both pre- and post-marketing.
Since the WHO Drug Dictionary contains a high percentage of product names that appear as co-medication, the need for manual investigations and fact-finding are reduced and the quality of coded data is increased.
WHO DD is sponsored, licensed, and maintained by the Uppsala Monitoring Centre (UMC). WHO DD updates are released Quarterly (March, June, September, and December) by the UMC.
Access
The eIT PMO manages the medical dictionary subscriptions and access to the latest updates for use by USAMRDC with no cost to the users.
These dictionaries can be imported into other USAMRDC systems to uniformly code clinical study data for submission to the FDA.
Currently, the eIT PMO Serious Adverse Event (SAE) and the eIT PMO Electronic Data Capture Clinical Research Data Management System (EDC-CRDMS) products utilize these dictionaries. Updates to both dictionaries are imported to the EDC-CRDMS and the SAE system as they become available.
The MedDRA Desktop Browser, ASCII files, and MedDRA User Guide are available in the EDMS Public Folder (EDMS account required).
WHO DD has a web-based access option hosted and maintained by the UMC. To obtain a user account to access the quarterly updates, please contact us. (links to Contact Us page) The WHO DD browser User Guide is available in the EDMS Public Folder (EDMS account required).