Table 2.

Factors contributing to “Lag” for approval of new oncology therapeutics in Japan

Stage in approval processCauses of delays
Delay in the start of developmentConcerns about cost and delays
Requests for additional data unique to Japan
Slow review and/or consultation times
Preference for positive phase II data prior to initiating
Prolonged trial conductLack of protected time for clinical research, high clinical workload
Lack of reimbursement and/or recognition for investigators
Inexperience in clinical research, limited support staff
Infrequent IRB meetings
Additional paperwork and/or requirements unique to Japan (J-GCP)
Patient reluctance (strong national healthcare system; concerns about safety; negative media releases; expectations about a positive outcome)
Prolonged J-NDA reviewLimited number of reviewers
Inconsistency in reviews and/or requirements

Abbreviations: J-GCP, Japan Good Clinical Practice; J-NDA, Japan New Drug Application.