The Ministry of Health, Labour and Welfare (MHLW) launched the “One-Stop Service Platform (OSSP)” (hereinafter referred to as “ENSEMBLExJ” Project) to facilitate the smooth introduction of products developed by overseas emerging biopharma (EBP) in Japan.
This project will be implemented by the National Centers in cooperation with the Clinical Research Core Hospitals.
In this project, the Pharmaceuticals and Medical Devices Agency (PMDA) will give priority to handling formal consultations in cooperation with ENSEMBLExJ.
One-Stop Service Platform by ENSEMBLExJ (NCCJ website)
Coordination between the One-Stop Service Platform (OSSP) and PMDA[56.7KB]
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