EMA Medicine finder

Published by

clinical medicine Non-Clinical Quality Regulatory Advice Scientific Advice

EMA Medicine finder helps find information on medicines authorised for human or veterinary use. You can find these by including the medicine’s name or its active substance. It shows information on centrally authorised medicines – medicines that EMA evaluated.

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Emergency Task Force

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clinical Non-Clinical Quality Regulatory Advice Scientific Advice

The European Medicines Agency’s (EMA) Emergency Task Force (ETF) provides scientific advice to developers of medicines used in declared or potential public health emergencies and threats.

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INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)

Published by IRDiRC

Drug Development Advice Early Access Support Regulatory Advice Regulatory Affairs Scientific Advice Targeted Engagement for Regulatory Advice

Through a CBER Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/Toxicology, and/or clinical aspects of the development program

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Stakeholders interactions – Professional affairs and Community Engagement

Published by IRDiRC

Clinical Trial Community Engagement Early Access Support Early Stage Interaction Patient Advice Professional Affairs Regulatory Advice Regulatory Affairs Scientific Advice

Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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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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Neglected and Tropical Diseases Priority Review Voucher

Published by IRDiRC

Early Access Support Neglected and Tropical Disease Priority Review Voucher Regulatory Advice Regulatory Affairs Scientific Advice

This 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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PMDA consultations

Published by IRDiRC

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

PMDA 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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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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