Consultations on Pharmacogenomics / Biomarkers (As part of PMDA consultations)

Published by IRDiRC

Regulatory Affairs Early Access Support Biomarker Scientific Advice MHLW or PMDA Regulatory Pharmacogenomics PMDA

Consultations on Pharmacogenomics / Biomarkers is one of the PMDA consultations. The purpose of this consultation is to provide general scientific advice for utilization of pharmacogenomics or biomarkers that are not specified in a certain product.

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Conditional Early Approval System for Medical Devices

Published by IRDiRC

Regulatory Affairs Early Access Support Medical Device MHLW or PMDA Regulatory PMDA Conditional Early Approval System CEASD

Conditional Early Approval System is a system to put highly useful and effective medical devices for treating serious diseases into practical use as early as possible.

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Consultations on Pharmacogenomics / Biomarkers (As part of PMDA consultations)

Conditional Early Approval System for Medical Devices