Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start- up Companies

Published by EATRIS

Target Validation Drug DevelopmentDrug RepurposingSmall MoleculeDrug Discovery GuidelineResearch and Drug DevelopmentNCATSNIH

This manual contains guidelines to develop therapeutic hypotheses, target and pathway validation, proof of concept criteria and generalized cost analyses at various stages of early drug discovery. Various decision points in developing a New Chemical Entity (NCE), description of the exploratory Investigational New Drug (IND) and orphan drug designation, Drug Repurposing and drug delivery technologies are also described and geared toward those who intend to develop new drug discovery and development programs.

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Exploring the new horizons of Drug Repurposing: A vital tool for turning hard work into smart work

Published by European Journal of Medicinal Chemistry

Research and Drug DevelopmentClinical TrialDrug DiscoveryDrug RepurposingLead Molecule

This review provides different approaches for Drug Repurposing and addresses recent developments and future scope of drug repositioning strategies. In addition provides a list of repurposed drugs and repurposing resources.

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Drug Repurposing: progress, challenges and recommendations

Published by Nature Reviews Drug Discovery

Research and Drug DevelopmentDrug DiscoveryDrug Repurposing

In this Article, it is presented approaches used for Drug Repurposing (also known as drug repositioning), discussed the challenges faced by the repurposing community and recommended innovative ways by which these challenges could be addressed to help realize the full potential of Drug Repurposing.

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Discovering New Therapeutics Uses for Existing Molecules (NTU) program, National Center for Advancing Translational Sciences (NCATS)

Published by IRDiRC

Drug RepurposingFundingNCATSResearch and Drug DiscoveryNTU-NCATSOrphan Drug

The NTU program aims to improve the process of developing new treatments for diseases by finding new uses for existing therapies that already have cleared several key steps along the development path. Existing or partially developed therapeutic candidates can be repurposed for use in new disease indications

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Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses)

Published by NCATS


The New Therapeutic Uses program aims to improve the process of developing new treatments and cures for disease by finding new uses for assets that already have cleared several key steps along the development path (also known as Drug Repurposing).

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The use or generation of biomedical data and existing medicines to discover and establish new treatments for patients with rare diseases – recommendations of the IRDiRC Data Mining and Repurposing Task Force

Published by Orphanet J Rare Dis.

Data MiningDrug Repurposing

This article reviews the past successes of data mining for Drug Repurposing, and planning for future biomedical research capacity, the DMR Task Force identified four strategic infrastructure investment areas to focus on in order to accelerate rare disease research productivity and drug development: (1) improving the capture and sharing of self-reported patient data, (2) better integration of existing research data, (3) increasing experimental testing capacity, and (4) sharing of rare disease research and development expertise. Additionally, the DMR Task Force also recommended a number of strategies to increase data mining and repurposing opportunities for rare diseases research as well as the development of individualized and precision medicine strategies.

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