Chapter 4 - Regulatory Requirements

Abstract

This chapter describes the current legislation and guidelines governing the conduct of clinical trials within country-specific and global contexts. Although many of these guidelines have been harmonised globally [such as International Council for Harmonization-Good Clinical Practice (ICH-GCP)], they are often enforced in accordance with country-specific legislation resulting in varying regulatory requirements and processes. Medicine Regulatory Authorities (MRAs) and Institutional Review Boards (IRBs) across the world must ensure that all clinical trials of both nonregistered medicines, comply with the necessary requirements for safety, quality, and efficacy prior to participant enrollment. Only once approval is received from each country-specific MRA (and there may be more than one) as well as the IRB may the trial commence. This chapter provides general oversight of regulatory processes in several countries as well as guidance as to where and how to access the documentation required for a clinical trial application (CTA). The regulatory submission process is the rate-limiting step of any clinical trial and significantly impacts on trial timelines. It is thus in the applicants best interest to ensure that they are familiar with each regulatory bodies' submission requirements and have an understanding of to what degree the country's legislation enforce these regulatory requirements.