Life Sciences Resource Archive

Curated collection of regulatory guidelines, templates, and industry resources

Regulatory Affairs

EMA Procedural Advice

Official EMA guidance on regulatory procedures and submission requirements

PDF 3.2 MB Updated: Dec 2024
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EU Marketing Authorization Template

Official EU template for marketing authorization applications

PDF 1.8 MB Version: 2024.1
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ICH M4 CTD Format Guidelines

International guidelines for Common Technical Document format

PDF 2.1 MB ICH M4(R4)
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Clinical Trials

EU Clinical Trials Regulation

Complete text of EU Regulation 536/2014 on clinical trials

PDF 892 KB Official Text
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ICH GCP Guidelines

International Conference on Harmonisation Good Clinical Practice guidelines

PDF 1.4 MB ICH E6(R2)
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CTIS User Manual

Official user manual for the Clinical Trials Information System

PDF 5.2 MB Version: 4.1
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Pharmacovigilance

GVP Module I - Pharmacovigilance Systems

EU Good Pharmacovigilance Practices Module I guidance

PDF 1.2 MB Rev 4 - 2017
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GVP Module VI - Risk Management

Guidance on risk management systems and risk minimization measures

PDF 1.8 MB Rev 2 - 2017
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MedDRA Browser Guide

User guide for Medical Dictionary for Regulatory Activities

PDF 2.4 MB Version 27.0
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Quality & Compliance

EU GMP Guidelines

European Union Good Manufacturing Practice guidelines

PDF 3.1 MB Current Version
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ICH Q7 Good Manufacturing Practice

International guidelines for active pharmaceutical ingredients

PDF 1.9 MB ICH Q7
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Data Integrity Guidelines

EMA guidance on data integrity in pharmaceutical quality systems

PDF 890 KB 2023
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Guidelines & SOPs

EMA Scientific Guidelines

Complete index of EMA scientific guidelines by therapeutic area

PDF 2.8 MB 2024 Edition
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WHO TRS Guidelines

World Health Organization Technical Report Series guidelines

PDF 4.2 MB TRS 1019
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FDA Guidance Documents

Compilation of FDA guidance documents for industry

PDF 1.7 MB 2024 Update
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