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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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Advisory CommiteeApproval Advisory CommitteeEarly Access SupportRegulatory AffairsScientific AdviceTechnical AdviceAdvisory committees (AC) provide independent advice and recommendations the US FDA on scientific and technical matters related to the development and evaluation of products regulated by the FDA
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Breakthrough Therapy DesignationEarly Access SupportExpedited ProgrammeRegulatory AdviceRegulatory AffairsProcess designed to facilitate the development and expedite the review of drugs intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
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Accelerated AprovalEarly Access SupportRegulatory AdviceRegulatory AffairsFDA-AA is designed to support the development of drugs that treats serious or life- threatening conditions AND generally provides a meaningful advantage over available
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Early Access SupportProduct Development ProgrammeRegulatory AffairsScientific AdviceType A MeetingType C Meeting“Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important Safety issue
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Early Access SupportEnd of Phase 2 MeetingMilestone MeetingPre-NDA MeetingRegulatory AdviceRegulatory AffairsScientific AdviceThe default drug development program includes three milestones, or Type B meetings. The earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.
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Early Access SupportMilestone MeetingPre Investigational New Drug InteractionPre-NDA MeetingRegulatory AffairsScientific AdviceA pre-IND meeting is an FDA milestone meeting also known as Type B meeting . In these meetings the drug sponsor seeks FDA feedback about the quality, non- clinical and clinical development plan. The Pre-IND meetings are not mandatory.
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Advanced TherapyEarly Access SupportRegenerative Medicine Advanced Therapy DesignationRegulatory AffairsThe RMAT Designation is analogous to the Breakthrough Designation designed for traditional drug candidates but applies to regenerative medicine treatments, and allows companies to interact with the FDA more frequently during the clinical development of the therapy. An RMAT-designated therapy is eligible for priority review and accelerated approval.
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Early Access SupportNeglected and Tropical DiseasePriority Review VoucherRegulatory AdviceRegulatory AffairsScientific AdviceThis program grants a priority review voucher (PRV) from the US Food and Drug Administration (FDA) to sponsors of certain tropical disease product application
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Early Access SupportOrphan Drug DesignationPaediatric MedicineRare Paediatric Disease DesignationRegulatory AffairsThe FDA grants rare pediatric disease designation for diseases with serious or life- threatening conditions that affect people from birth to 18 years of age, that affect fewer than 200,000 people in the U.S.
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