Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines

The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG.

The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support regulatory and healthcare decision making. This was set out in the ICH Reflection paper on Renovation of Good Clinical Practice and the ICH E6(R3) Concept Paper. A Business Plan was developed.

The UK Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) are being updated following the UK’s departure from the European Union (EU) and the changes to the legislation have recently been subject to public consultation. The Government response to the consultation on legislative proposals for clinical trials confirms that the principles of GCP, as set out in ICH E6(R3) section II will replace the current GCP principles in the UK legislation that are based on outdated EU legislation. Therefore, as stated in the Government response section 3.7, compliance with the ICH E6(R3) GCP Principles and not the entirety of the guideline will become a legal requirement in the UK. 

ICH E6(R3) GCP Principles, Annexe 1, Glossary and the 3 Appendices have now reached Step 2 and are available for public consultation. 

(Note: Annexe 2 is currently being developed by an ICH EWG subgroup and a concept paper has been agreed by the ICH Management Committee.)