Uses of MedDRA

USES OF MedDRA

From its inception, MedDRA was intended for use throughout the regulatory process of the development of medicines in humans and also during their subse-quent clinical use. In clinical studies, it can be used for recording baseline medical and social history, the names of clinical investigations and for recording and reporting adverse events. It can also be used to describe adverse events in the Investigator Brochure or Development Core Safety Information, in annual safety reports and in the safety sections of interim and final study reports. In the European Union (EU), its use is required for the electronic reporting of Suspected Unexpected Serious Adverse Drug Reac-tions (SUSARs) to the Clinical Trial Module of the Eudravigilance regulatory safety database. The ICH E4M guideline (ICH Harmonised Tripartite Guide-line, 2005) on the Common Technical Document recommends the use of MedDRA in summary tables of adverse events to be included in the registra-tion dossier for a new product (although the tables published as examples in the final guideline itself do not seem to use MedDRA!).

For marketed medicines, MedDRA may be used to present adverse reactions in the Company Core Safety Information and in reference safety information such as the package insert and Summary of Product Char-acteristics (SPC). In the EU, some regulators have requested the use of MedDRA for describing adverse reactions in the SPC, although at the time of writing this is not required by regulations.

The use of MedDRA for recording and for the expedited reporting of adverse reactions for marketed products is required by regulation in the EU and Japan. The mandatory use of MedDRA for this purpose in the United States is anticipated with the (presently delayed) implementation of the FDA’s Proposed Rule on Safety Reporting Requirements for Human Drug and Biological Products (FDA, 2003). The use of MedDRA is recommended for expedited reporting to Health Canada and a requirement for its use for expe-dited reporting is also described in Australian regula-tory guidelines.

The scope of MedDRA for use in individual case safety reports is summarised in the ICH E2B(M) guidelines (ICH Guideline on Clinical Safety Data Management, 2005), to include coding of the follow-ing data fields: medical history of disease and surgical procedures; past drug history – indications and reac-tions; adverse reaction or event; therapeutic indica-tion for suspect drug; effects of rechallenge; reported and autopsy-determined cause of death; sender’s diagnosis. An additional use would be in the record-ing of findings of investigations of the adverse event. MedDRA is also appropriate for use in the Peri-odic Safety Update Report (PSUR) in line-listings and summary event tabulations, although it is not explic-itly required by regulation.