Posted 12 June 2017
By Michael Mezher
The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA.
According to ICH, MedDRA is now used by more than 5,000 subscribers in 103 countries.
"This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health," ICH said following MedDRA's management board meeting in Montreal last May.
MedDRA, which was initially developed to provide standardized medical terminology for regulatory purposes, is available to regulators at no cost and to drugmakers on a sliding scale based on the company's annual revenue.
According to ICH, the MedDRA Maintenance and Support Service Organization (MSSO) will continue to focus on expanding the use of the dictionary globally and look to make MedDRA and other medical terminologies interoperable.
ICH also said its M1 Points to Consider (PtC) Working Group has developed "condensed versions" of its documents that will be translated into nine MedDRA languages other than English and Japanese, as full versions of the document are already available in those languages. According to ICH, these condensed translations will be available later this year.
ICH also announced that its planned companion documents to the English and Japanese Points to Consider documents will be available sometime in 2018. The companion documents aim to provide "more detail guidance, examples and 'questions and answers' on topics of regulatory importance such as data quality and medication errors," ICH said.