Yeda Research and Development Company Ltd. is the commercial arm of the Weizmann Institute of Science. Yeda holds an exclusive agreement with the Weizmann Institute to commercialize the unique intellectual property developed by the scientists.
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Designated Intractable Diseases (Designated Nan-byo)
Published by IRDiRC
Act on Medical CareEarly Access SupportMHLW or PMDA RegulatoryNan-byo DesignationRare DiseaseRegulatory AffairsDefinition of designated Nan-byo is provided in the law named “Act on Medical Care for Patients with Intractable/Rare Diseases”. Patients with designated Nan-byo can receive financial support for medical treatment
View this resource Bookmark this resourceAMED provides seamless funding from basic research to practical application and adequate implementation of clinical studies/trials, in order to promote drug development in Japan
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Conditional and Time-limited Authorization of Regenerative Medical Products
Published by IRDiRC
Advanced Therapy ProcedureCTARPMarketing AuthorisationMHLW or PMDA Regenerative Medical ProductsPMD ActRegulatory AffairsA regulatory framework for the approval of regenerative medical products to benefit the patients with unmet medical needs under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)
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Japan Compassionate Use Programs
Published by IRDiRC
Clinical DevelopmentCompassionate Use ProgrammeEarly Access SupportMHLW or PMDA RegulatoryRegulatory AffairsA system for patients with life-threatening conditions without effective a treatment to gain access to unapproved investigational medical products.
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Study Group on Unapproved and Off-label Drugs of High Medical Need
Published by IRDiRC
Early Access SupportMHLW or PMDA RegulatoryRegulatory AffairsScientific AdviceThe objective of the Study Group is to evaluate medical need, investigate necessary studies for market approval, and request company to develop medicinal products to solve the problem of unapproved drug and off- label use with medical need. Public consultations are conducted to gather requests from public.
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Conditional Early Approval System for Medical Devices
Published by IRDiRC
CEASDConditional Early Approval SystemEarly Access SupportMedical DeviceMHLW or PMDA RegulatoryPMDARegulatory AffairsConditional 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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Conditional Early Approval System for Drugs
Published by IRDiRC
Conditional Early Approval SystemEarly Access SupportMHLW or PMDA RegulatoryRegulatory AffairsConditional Early Approval System is a system to put highly useful and effective drugs for treating serious diseases into practical use as early as possible.
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Consultations on Pharmacogenomics / Biomarkers (As part of PMDA consultations)
Published by IRDiRC
BiomarkerEarly Access SupportMHLW or PMDA RegulatoryPharmacogenomicsPMDARegulatory AffairsScientific AdviceConsultations 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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PMDA consultations
Published by IRDiRC
Early Access SupportMHLW or PMDA RegulatoryRegulatory AdviceRegulatory AffairsScientific AdvicePMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and regenerative medical products as well as on data for regulatory submissions. For designated orphan drugs, PMDA offers Priority consultation.
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