AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION AND MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MUTUAL RECOGNITION

In 2017 the Food and Drug Administration (FDA) of the United States and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom signed a mutual recognition agreement (MRA). This report summarizes the entirety of the FDA-MHRA MRA, details the inspection process of both regulatory agencies, and analyzes the foundation of the MRA that is regulatory harmonization. Furthermore, the report attempts to analyze potential effects of the recently signed FDA-MHRA MRA by comparing good manufacturing practices (GMP) enforcement action data. Although the report finds no major effects from the GMP enforcement action data, due to insufficient data and the COVID-19 pandemic, the report lays a framework for future GMP enforcement action data analysis.