New translations of package inserts from the Pharmaceutical and Medical Devices Agency (PMDA), Japan, as well as updated translations of existing package inserts, are now available on PharmGKB.
The PMDA is a regulatory agency responsible for scientific reviews for the approval of drugs or medical devices, as well as safety monitoring after approval. The PMDA website provides PDF copies of package inserts for approved drugs, though these inserts are only available in Japanese. Previously, PharmGKB had used a 2013 paper by Shimazawa and Ikeda that selected PMDA inserts to examine for PGx information based on the FDA's Table of Pharmacogenomic Biomarkers in Drug Labeling as it existed on October 2012, and then provided translations of any PGx information present in the PMDA package inserts. Though this paper was useful, additional drug labels with PGx information have been added to the FDA table in the past 4 years, and PharmGKB has also identified drug labels with PGx information independently.
Now, through a collaboration with the Japanese Society of Pharmacogenomics, as well as Silicon Valley Tech KK, PharmGKB is able to provide translations of a wider set of PMDA labels, as well as more extensive translations of some labels.
Some of the new labels available include:
An overview of all the drug labels on PharmGKB can be viewed here.
PharmGKB thanks the Japanese Society of Pharmacogenomics for its diligent work in translating these labels, and helping to make them available to the public.