For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
REGULATORY
Setting “Presumed Efficacy” Criteria Would Be Difficult; Xocova Decision Reasonable: PMDA Chief
Japan’s new emergency approval system was applied for the first time in 2022 after it was deemed possible to reasonably “presume” efficacy, but it would be difficult to establish clearcut criteria for such presumption, Yasuhiro Fujiwara, chief executive of the…
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