{"id":234,"date":"2026-08-26T12:52:16","date_gmt":"2026-08-26T12:52:16","guid":{"rendered":"https:\/\/dev.ich.org\/?page_id=234"},"modified":"2026-10-14T15:14:17","modified_gmt":"2026-10-14T15:14:17","slug":"meddra","status":"publish","type":"page","link":"https:\/\/dev.ich.org\/index.php\/guidelines-products\/meddra\/","title":{"rendered":"MedDRA"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n
\n \t\t\tHome \/ Guidelines & Products<\/span>\n\t\t\n<\/div>\n\n<\/div>\n
\n
\n \t\t\t

About MedDRA<\/h1>\n\t\t
\n \t\t
\n\t\t\t\t\t\t\t\t\t

MedDRA is a rich and highly specific, standardised medical terminology developed in the 1990s. It is now updated twice per year in 27 languages.<\/p>

MedDRA facilitates the sharing of regulatory information internationally for medical products used by humans, including pharmaceuticals, vaccines and drug-device combination products.<\/p>

A powerful tool, MedDRA is used for registration, documentation and safety monitoring of medical products before and after a product has been authorised for use.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\"\"\/\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n
\n
\n \t\t\t

MedDRA governance<\/h2>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The MedDRA Steering Committee is responsible for the operational aspects of MedDRA and reports to the ICH Management Committee.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t\t\n\tRead More\n<\/a>\n\t\t\n<\/div>\n\t\t\t\"\"\/\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t\t

ICH M1PtC Working Group\u200b<\/h2>\n\t\t
\n \t\t
\n\t\t\t\t\t\t\t\t\t

The\u00a0ICH M1 Points to Consider (PTC) Working Group<\/b><\/span><\/a>\u00a0develops and maintains two PTC documents on the use of MedDRA, updated annually with the March release:\u00a0\u200b<\/span><\/p>