Drug- Development

Core Regulatory Hub

ICH- Safety and technical guidances (S, M, Q, E series)

Primary source for ICH safety guidances and Q&As.

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Core Regulatory Hub

FDA- Regulations, guidance documents, IND and drug approval pathways

CFR Title 21 resources, IND guidance, FDA NAMs program and regulatory policy updates

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Core Regulatory Hub

EMA- European regulatory guidance and position papers on nonclinical and NAM acceptance

EMA guidance and scientific advice pages relevant to nonclinical strategy

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ICH Guidelines

ICH S1B(R1)- use of in vitro assays in weight‑of‑evidence phototoxicity / photomutagenicity assessments

Guidance and Q&As on integrating in vitro tests into safety assessments

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ICH Guidelines

ICH S5(R3)- developmental and reproductive toxicology including in vitro, ex vivo and non‑ mammalian approaches

Updated options for DART assessment and nonmammalian models.

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ICH Guidelines

ICH M7- in silico (Q)SAR approaches for mutagenicity assessment of impurities

Recommended workflows and regulatory expectations for computational impurity assessment

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ICH Guidelines

ICH S10- phototoxicity guidance including in chemico and in vitro methods

Standardized phototoxicity testing approaches and acceptance criteria

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ICH Guidelines

ICH E14 / S7B Q&As- cardiac safety, including translational electrophysiology and hiPSC‑ CM considerations

Clarifications for integrating nonclinical electrophysiology data into regulatory packages

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ICH guidelines (NAMs)

ICH S5 (R3)

Detection of reproductive and developmental toxicity

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ICH guidelines (NAMs)

ICH S10

Photosafety assessment of pharmaceuticals

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ICH guidelines (NAMs)

ICH M7 (R2)

Assessment and control of mutagenic impurities

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ICH guidelines (NAMs)

FDA guidance: in silico, in chemico, in vitro skin sensititization

FDA's guidance documents for skin sensitization

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ICH guidelines (NAMs)

OECD-Ocular: 437, 438, 460, 491, 492, 494

OECD guidelines on ocular toxicity

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ICH guidelines (NAMs)

OECD-Skin: 439

OECD guidelines in vitro skin irritation

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3R And NAMs Guidelines

OECD Test Guidelines and GLP Principles- standardized assays and acceptance criteria for regulatory toxicology

Test methods and GLP principles underpinning regulatory study acceptance

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3R And NAMs Guidelines

NC3Rs- resources and case studies on replacement, reduction, and refinement of animal use

Practical case studies and guidance for implementing 3R strategies

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3R And NAMs Guidelines

EURL‑ ECVAM / EU Reference Laboratory — validation and acceptance resources for alternative methods

Validation pathways and supporting documentation for NAMs

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Key Statutory / Submission References

21 CFR 312.23- IND content and format requirements

Legal requirements for IND submissions and required nonclinical elements

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Key Statutory / Submission References

ICH M4 (CTD)- Common Technical Document structure for dossier assembly

Recommended dossier structure for regulatory submissions (nonclinical modules)

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Key Statutory / Submission References

FDA NAMs Program & FDA Modernization Act initiatives

FDA efforts and pilot programs to increase regulatory acceptance of NAMs and modernize preclinical testing

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Government Programs And Initiatives

Tox21 consortium

High‑ throughput screening datasets and in vitro toxicology resources

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Government Programs And Initiatives

ISTAND

Advanced funding and standardization efforts for novel safety methods and alternatives

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Government Programs And Initiatives

DARPA programs

Advanced funding and standardization efforts for novel safety methods and alternatives

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Government Programs And Initiatives

Roadmap to Reducing Animal Studies in Preclinical Safety (FDA/consortium white papers)

Strategic reports and roadmaps on lowering reliance on animal studies

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Consortia, Translational And Qualification Partners

IQ Consortium- translational science and regulatory science deliverables

Industry consortia outputs on biomarkers, translational models and regulatory engagement

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Consortia, Translational And Qualification Partners

PSTC (Predictive Safety Testing Consortium)- biomarker qualification and translational safety tools

Qualified biomarkers and case studies for safety translation

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Consortia, Translational And Qualification Partners

HESI (Health and Environmental Sciences Institute)- cross‑sector science collaborations

Multi‑stakeholder projects on safety science and NAM validation

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Consortia, Translational And Qualification Partners

EFPIA- European industry collaboration and guidance

EFPIA position papers and collaborative projects on R&D and regulatory science

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