The Medical Dictionary for Regulatory Activities (MedDRA) is an
internationally recognized set of terms used to facilitate the
regulation of medical products for humans, including
biopharmaceuticals, medical devices and vaccines. Developed by
the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
(ICH), MedDRA terminology is used throughout the regulatory
process to enter, retrieve, analyse and present data both before
and after a medical product has been authorized for sale. In
addition, MedDRA enables the electronic transmission of adverse
event reporting, in both pre- and post-marketing phases. MedDRA
serves a vital public health need. It allows health authorities
and the biopharmaceutical and medical device industries within
and between countries to accurately and easily share information
regarding pre- and post-market medical product registration,
including safety monitoring of products. Major regulatory
authorities throughout the world a