All drugs have safety concerns throughout their development. However, they are eventually approved for use by national health authorities on the basis that the benefits outweigh the risks through evidence provided by clinical trial research. The approval process and degree of regulation for clinical trial conduct differs across regions. A comparative analysis between two regulatory environments existing in these regions was done via literature review, case studies and through interviews to capture the experiential perspectives of key individuals with good working knowledge These markets: the FDA, considered a regulated/ stringent market, and Botswana, considered a semi-regulated market, were examined to provide understanding on what effects the degree of implementation of clinical trial regulations have on Investigational New Drug (IND) and New Drug Approval (NDA) approval timelines.
Learning Objectives:
To compare how clinical trials are regulated in a stringent and a semi-regulated market.
To analyze the degree of implementation of Clinical Trial Regulations in terms of Investigational New Drug application approval, monitoring, inspections and audits, ethics committee and approval/withdrawal guidelines.
To compare the effects of stringent regulation and semi-regulation on Investigational New Drug applications and identify gaps for improvement.