Advanced Bio,
People-centered Value Creation

Speaker: Junko Sato (PMDA)

Q1

PV departments must pay attention to safety information updates from international regulatory authorities (e.g. label changes, safety warnings or letters, etc.). Does your regulator have quantifiable criteria for assessing the credibility of other regulators? (e.g. indicators such as the workforce of a regulatory authority's safety information department).

A1

PMDA is always paying attention to risk minimization activities implemented by other regulatory authorities. The activities taken by other regulatory authorities are used as a trigger for PMDA's assessment. PMDA's activities are taken by own discretion. We do not copy and paste measures taken by other regulatory authorities like a rubber stamp. Therefore, we do not assess the credibility of other regulatory authorities.