Table 4.

Summary of the regulatory and approval process for clinical trials in Japan

PMDA-clinical trial notification• Early consultation recommended
• Follow ICH recommendations for preclinical data
• Studies must address PK, PD, and PG considerations for Japanese patients, including ADME
IRB Approval Contract and budget• Required
• Standard method for cost calculation of clinical trials, but overhead costs varies by institutions and is negotiated individually with each institution on the basis of unique and complex requirements.
• In general full cost retrieval required, including the cost of unplanned investigations
• Interdepartmental coordination challenging (relevant when correlative studies are included)
IDMC• Usually required even for phase I trials
• If international IDMC in place, local IDMC may not be necessary

NOTE: ADME, absorption, distribution, metabolism, and excretion; PK, pharmacokinetic; PD, pharmacodynamic; PG, pharmacogenetic; IDMC, Independent Data Monitoring Committee.