MedDRA to become implemented in WHO's Vigibase.

The World Health Organization and the International Conference on Harmonization (ICH) have announced the implementation of MedDRA in the WHO global individual case safety reports (ICSR) database (Vigibase), thus completing a one-year project to make Vigibase processes as compatible with MedDRA as they are currently with WHO-ART.

Vigibase is a unique pool of international drug safety data which has been collected from countries participating in the WHO International Drug Monitoring Program going back as far as 1968. It currently comprises almost four million ICSRs. Member countries have access to the collected data and analyze it in order to investigate potential Adverse Drug Reaction (ADR) signals. Single reports, statistical reports and line listings can also be requested by pharmaceutical companies and academia.

Prior to this project, all reported adverse drug reactions were coded and entered into Vigibase using WHO-ART, which is WHO's reporting language. MedDRA terms received by the UMC were converted to WHO-ART before entry into Vigibase.

With MedDRA fast becoming the standard coding terminology in the ICH regions and beyond for coding ADRs, indications and disease information, MedDRA-coded data is now being received from an increasing number of countries. Implementation of MedDRA in Vigibase is seen as an important step in increasing Vigibase's use for signal detection, while ensuring the integrity of MedDRA-coded safety data.

Now that MedDRA is being implemented by WHO, data can now be entered directly into Vigibase in either MedDRA or WHO-ART, while all Vigibase outputs can be made to display data in either MedDRA or WHO-ART, or in both terminologies. In addition, Standardized MedDRA Queries (SMQs), used to aid in the identification and retrieval of potentially relevant reports from MedDRA-coded databases are also in the process of being implemented.

The UMC and the MedDRA Management Board believe that MedDRA's implementation in Vigibase will provide a global repository of MedDRA-coded safety data that can be used as a substantial tool for pharmacovigilance and of significant benefit to patient safety and public health.