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Abstract

The International Conference on Harmonization (ICH) is a unique multinational effort involving globalization of the pharmaceutical industry. In response to a need perceived by both industry and regulatory authorities for a common medical terminology designed for regulatory purposes, the Medical Dictionary for Regulatory Activities (MedDRA®) was developed under ICH auspices.

As a dynamic terminology, MedDRA has undergone review and refinements by its associated Expert Working Group to facilitate analysis and presentation of data. The MedDRA Maintenance and Support Services Organization is responsible for maintaining and updating the terminology, utilizing user experience and feedback.

While not the first coding terminology designed for adverse reaction reporting, MedDRA reportedly offers advantages over previous terminologies. Further, a common terminology provides for greater ease of analysis and data transmission both within and between countries.

However, no medical terminology is without limitations, particularly with respect to coding issues and specific clinical entities. These limitations must be recognized and considered in the performance of pharmacovigilance and pharmacoepidemiology, if the terminology's utility as a safety tool is to be maximized.

Keywords

Adverse Reporting MedDRA®Pharmacovigilance Pharmacoepidemiology

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References

International Conference on Harmonization Web site: www.ifpma.org/ich1.html; www.ifpma.org/ich5m.html; www.ifpma.org/ichMedDRA.html.

MedDRA Maintenance and Support Services Organization Website: www.meddramsso.com..

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Adverse Event Reporting and Standardized Medical Terminologies: Strengths and Limitations

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