New Study Reveals Geographic Distribution of FDA's GCP Inspections
A comprehensive analysis of FDA GCP inspections from 2016-2018 shows that 1,275 inspections were conducted across 347 marketing applications, with 63% of clinical investigator inspections performed in the U.S. and the remainder primarily in Europe, highlighting the need for expanded global inspection coverage.
A groundbreaking study published in the Journal of Clinical Data Management analyzes the scope and geographic distribution of FDA's Good Clinical Practice (GCP) inspections between 2016 and 2018. The research reveals that while 1,275 inspections were conducted across 347 marketing applications, the vast majority occurred in the United States (63%) and Europe, with limited coverage in other regions including Africa. This geographic imbalance highlights the critical need for strengthening GCP compliance and inspection readiness in underrepresented regions, directly supporting HACT's mission to build clinical research capacity in the Horn of Africa.