Study Group on Unapproved and Off-label Drugs of High Medical Need

Published by IRDiRC

Early Access Support MHLW or PMDA Regulatory Regulatory Affairs Scientific Advice

The 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

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

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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Conditional Early Approval System for Drugs

Published by IRDiRC

Conditional Early Approval System Early Access Support MHLW or PMDA Regulatory Regulatory Affairs

Conditional 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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Product specific- pre approval advisory committee

Published by IRDiRC

Advisory Commitee Approval Advisory Committee Early Access Support Regulatory Affairs Scientific Advice Technical Advice

Advisory 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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FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Breakthrough Therapy Designation Early Access Support Expedited Programme Regulatory Advice Regulatory Affairs

Process 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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FDA Expedited Program for serious conditions – Priority Review Designation

Published by IRDiRC

Accelerated Aproval Early Access Support Regulatory Advice Regulatory Affairs

FDA-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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Published by IRDiRC

Biologics License Application Marketing Authorisation New Drug Application Priority Review Designation Priority Review Voucher Regulatory Advice Regulatory Affairs

A Priority Review designation results in an abbreviated PDUFA mandated goal date for a Biologics License Application (BLA) or a New Drug Application (NDA), from 10 months (under standard procedure) to 6 months.

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FDA Type C, A meetings

Published by IRDiRC

Early Access Support Product Development Programme Regulatory Affairs Scientific Advice Type A Meeting Type 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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FDA Milestones meetings – Type B

Published by IRDiRC

Early Access Support End of Phase 2 Meeting Milestone Meeting Pre-NDA Meeting Regulatory Advice Regulatory Affairs Scientific Advice

The 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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Pre Investigational New Drug (IND) interactions

Published by IRDiRC

Early Access Support Milestone Meeting Pre Investigational New Drug Interaction Pre-NDA Meeting Regulatory Affairs Scientific Advice

A 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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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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