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Characteriation of Clinical Data Packages Using Foreign Data in New Drug Applications in Japan
Author(s) -
Tanaka M,
Nagata T
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100346
Subject(s) - guideline , harmonization , medicine , clinical research , drug approval , clinical practice , drug , pharmacology , family medicine , pathology , physics , acoustics
The objective of this research was to characterize clinical data packages (CDPs) of new drug applications (NDAs) using foreign data based on the International Conference on Harmonization (ICH) E5 guideline. Official review reports of NDAs approved in Japan between January 1999 and April 2005 were examined. Those NDAs considered by the official reviewers to be approved based on the ICH E5 guideline (E5‐NDAs) were identified and classified into six categories of approval requirements in Japan. The details of pivotal clinical efficacy studies in the CDPs were examined. Forty‐one NDAs were identified as E5‐NDAs. Pivotal clinical studies conducted in Japan were required by the E5‐NDAs, except for nine of those in which the foreign clinical studies reduced Japanese clinical studies in the CDPs. Given the differences in approval requirements among regions, the acceptability of foreign clinical data to Japanese approval is limited. Clinical Pharmacology & Therapeutics (2008); 84 , 3, 340–346 doi: 10.1038/sj.clpt.6100346