Notes
MedDRA = Medical Dictionary for Regulatory Activities; it is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process.
Reference
International Council for Harmonisation. ICH Assembly, Montreal, Canada, May/June 2017. Internet Document : 19 Jun 2017. Available from: URL: http://www.ich.org/ichnews/press-releases/view/article/ich-assembly-montreal-canada-mayjune-2017.html
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China FDA accepted as member of Swiss non-profit ICH. Reactions Weekly 1661, 1 (2017). https://doi.org/10.1007/s40278-017-33289-4
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DOI: https://doi.org/10.1007/s40278-017-33289-4