Good Clinical Practice (GCP) Regulations and Guidelines

Regulations

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

EU Commission Directive 2005/28/EC

Commission Directive (EU) 2017/1572

Declaration of Helsinki

UK Legislation

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

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) and Blood Safety and Quality (Amendment) Regulations 2008 - Statutory Instrument 941

USA Regulations

FDA Regulations relating to GCP and clinical trials

Guidelines

ICH E6 Guidelines for Good Clinical Practice

Medicines for Human Use - Eudralex

MHRA Serious Breaches Guidance

Clinical Trials Toolkit

MHRA Good Clinical Practice Guide (Grey Guide)

MHRA Good Clinical Practice: The Inspection Process

Click here to view the process which covers types of inspection, routine inspection process flowchart, submissions, what to expect during ruotine inspections, findings and reporting of ruotine inspections and triggered inspections.

International Compilation of Human Research  Standards- 2013 Edition

US Department of Health and Human Services link to to laws, regulations, and guidelines that govern human subjects research in 104 countries, as well as the standards from a number of international and regional organisations. Click here.

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.