REGULATORY
MHLW Proposes “Institutionalization” of Conditional Approval, Sakigake Schemes
With an eye on an amendment of the Pharmaceuticals and Medical Devices (PMD) Law, the health ministry has proposed the “institutionalization” of its conditional early approval system and sakigake fast-track designation scheme under the law in order to give them…
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





