Uses of MedDRA (Medical Dictionary for Regulatory Activities)
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.
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