MedDRA®: The tale of a terminology: Side Effects of Drugs Essay

Publisher Summary This chapter presents the various aspects of medical dictionary for regulatory activities terminology MedDRA ® . MedDRA ® is a clinically validated international medical terminology used by regulatory authorities and biopharmaceutical companies in both premarketing and post-marketing regulatory reporting. MedDRA ® is used for data entry, retrieval, evaluation, and presentation. It is one of the most successful of all the initiatives established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA ® was designed to classify a wide range of types of adverse events, such as signs, symptoms, diseases and diagnoses, therapeutic indications, qualitative results of investigations, surgical and medical procedures, health effects, malfunction of devices, and medical, social, and family history. MedDRA ® is distributed by subscription on a sliding scale fee based on company revenues. The main driver of MedDRA®'s growth and development continues to be the MedDRA ® user community. The maintenance and support services organization coordinates, facilitates, and promotes the development of MedDRA ® in a variety of ways, based on feedback from subscribers.