Execution of Regulatory &
Clinical Operation Strategy
As one of initial members of ICH, current clinical process in Japan has no difference from global GCP.
However, building a feasible clinical strategy which includes the consideration of investigators, staff as well as hospital bureaus are extremely critical.
Contingency strategies and risk management plan can help to ease the process.
With the goal to bring better treatment to Japanese patients faster, PMDA accepts JNDA package with global study data that includes Japanese patients.
However, clear clinical benefit to patients in Japan is necessary with scientific evidence.
Well-established PMDA consultation strategy with highly experienced professionals will facilitate reaching regulatory endorsement from PMDA.