UMC's Cross Reference Tool Japan (CRT Japan) directly matches Iyakuhinmei Data File (IDF) codes with WHO DDE codes, allowing for uniform coding of medicinal product data and faster submissions to regulatory authorities.
Japan’s national dictionary for coding clinical and drug safety data is the Iyakuhinmei Data File (IDF). IDF is used when reporting concomitant medication safety data to the Pharmaceuticals and Medical Devices Agency, PMDA.
"Using CRT Japan simplifies coding of medicinal product data"
In the rest of the world, the Uppsala Monitoring Centre (UMC) WHO Drug Dictionary Enhanced (WHO DDE) is the de facto standard for coding medicinal product information in clinical and safety data. UMC’s new Cross Reference Tool Japan (CRT Japan) allows direct matching of IDF and WHO DDE codes.
Until now, Japanese pharmaceutical companies and CROs who use IDF domestically and WHO DDE internationally have coded their data twice: first in IDF and then, following manual translation of Japanese drug and substance names into English, in WHO DDE. Multi-national companies active in Japan have also coded their clinical and safety data separately in both dictionaries.
CRT Japan replaces this time-consuming doublecoding by directly matching IDF and WHO DDE codes, a method that is both faster and more secure.
CRT Japan is always updated with the latest changes and additions made to WHO DDE and IDF. The mapping of codes is also uniformly consistent. This ensures high quality and avoids the uncertainties of in-house coding solutions.
CRT Japan also opens up the many powerful analysis tools incorporated in WHO DDE for data coded in the IDF dictionary. Japanese data can thus be analyzed using the exact same methods and terminologies as for international data, e.g. the Anatomical Therapeutic Chemical (ATC) classification system and Standardized Drug Groupings (SDGs).
SDGs can thus be used to identify protocol violations and drug-drug interactions in Japan with the same protocol as used internationally. Users can quickly identify concomitant medication that may affect the metabolism of their study drug – including metabolic pathways that could differ between Japanese and other populations.
Reporting between countries and within multi-national organizations is smoother and more reliable. CRT Japan’s automatic matching of IDF and WHO DDE clinical and safety data codes speeds code selection, ensures better data quality and interpretation, allows powerful analysis and smoothes communication.
Use of CRT Japan requires a valid subscription to WHO DDE and IDF. Access to IDF requires membership of MT Kyogikai, the Organization for Maintenance of Prescription Drug Re-examination Codes in Japan.
This is open to all life-science companies, as well as developers of software systems that support IDF, CRT Japan and WHO DDE. For more information about CRT Japan, contact UMC at firstname.lastname@example.org