Abstract
To improve pharmacovigilance or drug safety measures, it is important to facilitate international exchange of medicinal product information which is reported to each regulatory authority. However, in the current individual case safety report systems, the items and names used in describing medicinal products are different among the countries/jurisdictions, and, thus, this makes it difficult to promote the smooth and prompt international information exchange on medicinal products. To solve this issue, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) had initiated a topic referred to as “Data Elements and Standards for Drug Dictionaries” which was aimed to support the identification of medicinal products in all ICH regions, and considered the requirements for five medicinal dictionaries. Based on these requirements presented by ICH, in November 2012, the five international standards of electronic transmission model system for medicinal product information have been established by a project of International Organization for Standardization (ISO), referred to as “ISO-IDMP”. This tutorial paper overviews the international standards of ISO-IDMP, including the backgrounds and the current international activities for implementation, and discusses the particular issues that should be considered in Japan.
