Module 5 Presentations

05/07/2024

EU legislation is part of a broader global framework

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) • Process of scientific consensus to establish guidelines • Good Clinical Practices (GCP) • Declaration of Helsinki and related texts • ICH E6 (R2) dated 16Nov2017 • Good Manufacturing Practices (GMP) • Minimum production standards for production processes (MP) • Consistent high quality, appropriate for intended use, meet requirements (CTA, MA) • Pharmaceutical Inspection Co-operation Scheme (PIC/S) with 53 authorities • OECD’s Good Laboratory Practices (GLP) • Applies to the non clinical safety testing of pharmaceutical products

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

5

Introduction

• Whether CTD or CTR, the fundamentals of clinical trials remain the same • Underlying principles of legislation governing the conduct of clinical trials are to ensure the: • Rights, safety, dignity, well-being of subjects • Data generated should be reliable and robust • Interests of the subjects should always take priority over all other interests

Publication CTD

Entry in force CTD

1 st VHP guidance

Publication CTR

Entry in force CTR

End of CTR transition period

2014

2022

2001

2004

2009

2025

EU Clinical Trial Directive (CTD) Voluntary harmonization procedure (VHP)

Individual laws in eachMS

EU Clinical Trial Regulation (CTR)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

6