Annotated PMDA drug labels now available on PharmGKB

PharmGKB now has annotated drug labels available from the Pharmaceutical and Medical Devices Agency (PMDA), Japan.

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. However, these inserts are only available in Japanese, and until recently PharmGKB had been unable to search for or annotate PMDA package inserts containing relevant pharmacogenetic (PGx) information.

In a paper published in 2013 in the Journal of Clinical Pharmacy and Therapeutics, Shimazawa and Ikeda selected PMDA inserts to examine for PGx information based on the FDA's Table of Pharmacogenomic Biomarkers in Drug Labeling. In addition to a discussion of the differences in PGx biomarker information between labels from the United States, United Kingdom and Japan, the authors also provided a table in the supplementary information that gave translations of any PGx information present in the PMDA package inserts. Using these translations, PharmGKB was able to create annotated drug labels for the package inserts examined by Shimazawa and Ikeda that contained PGx information. As with the annotated FDA and EMA drug labels, PMDA labels are given a PGx level of evidence, and a PDF copy of the package insert with PGx information highlighted is available for each annotated label.

It is likely that there are other PMDA package inserts that contain PGx information, and PharmGKB welcomes any feedback regarding PGx information within PMDA package inserts or labels from other medicine agencies around the world.

See a list of drug labels available on PharmGKB:
PMDA labels on PharmGKB

Read the paper:
Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan
Shimazawa R, Ikeda M. Journal of Clinical Pharmacy and Therapeutics 2013; 38(6): 468-75. PMID 23895776.

Subscribe to ClinPGx Blog

Don’t miss out on the latest issues. Sign up now to get access to the library of members-only issues.