Good Clinical Practice (GCP) Legislation and Guidance

 

Regulations

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

02. EU Commission Directive 2005/28/EC (UPDATED LINK)

03. EU Commission Directive 2003/94/EC (UPDATED LINK)

04. Declaration of Helsinki

 

UK Legislation

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

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

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

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

 

USA Regulations

09. FDA Regulations relating to GCP and clinical trials

 

Guidelines

10. ICH M3(R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

11. ICH E6 Guidelines for Good Clinical Practice

12. Medicines for Human Use - Eudralex

13. MHRA Serious Breaches Guidance

14. NIHR Clinical Trials Toolkit

15. MHRA Good Clinical Practice Guide (Grey Guide) (UPDATED LINK)

16. ABPI phase 1 Guidance

17. Serious Breaches Guidance

 

MHRA Good Clinical Practice: The Inspection Process

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

 

International Compilation of Human Research Standards- 2013 Edition

US Department of Health and Human Services link to laws, regulations, and guidelines that govern human subjects research in 104 countries and the standards from several 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 has published an agreed Global GCP Auditing Guideline and supplemental Appendices on many specific audit types, effective April 2014. This is a unique, collaborative effort between the three societies to provide our members with guidance and a best practice approach to GCP auditing across regions.

Click here for more information (RQA members only)

 

RQA's (BARQA's) Regulations and Guidelines Archive 2009

Click here to view an archived regulations and guidelines document - while this information is no longer updated and may not be the most current, it may be beneficial from a historical perspective.

 

RQA's Good Clinical Practice webpage Click here