Good Clinical Practice (GCP) Regulations and Guidelines

EU Legislation

Commission Directive (EU) 2017/1572

New Clinical Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)

EU Commission Directive 2005/28/EC

Medicines for Human Use - Eudralex

UK Legislation

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 - Statutory Instrument 941

The Medicines for Human Use (Clinical Trials) Amendment  Regulations 2006 - Statutory Instrument 1928

The Medicines for human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - Statutory Instrument 2984

The Medicines for Human Use (Clinical Trials) Regulations 2004 - Statutory Instrument 1031

USA Regulations

Regulations: Good Clinical Practice and Clinical Trials | FDA 

Guidelines

ICH E6(R3) Final Guideline 2025 

Declaration of Helsinki

Medicines: clinical trials hub - GOV.UK

International Compilation of Human Research Standards, 2024 Edition 

The Global Guideline for GCP Audit

The Japan Society of Quality Assurance (JSQA), the Society of Quality Assurance (SQA) and the RQA have published an agreed Global GCP Auditing Guideline together with supplemental Appendices on a number of specific audit types, effective April 2014. This is a unique, collaborative effort between the three societies aimed at providing our members with guidance and best practice approach to GCP auditing across regions.

Click here for more information (members only)

Regulations and Guidelines Archive 2009

Click here to view an archived regulations and guidelines document - while this information is not the most current, it may nonetheless be beneficial from a historical perspective.