Risk based approach of post- approval changes in central America and Dominican republic, identifying opportunities for convergence with EMA and FDA

Abstract

In Central American countries (Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica and Panama) and Dominican Republic (DR) the approval timelines for major changes are described ranging from 12 to 18 months, these timelines are considerably extensive. Other countries or regions applying FDA post-approval change and EMA post-approval variation guidelines have timelines of 6 months or less (Hoath et al, 2016, Murray, 2016). The research aims to identify opportunities for alignment of the post-approval changes categories of Central America (CA) and Dominican Republic (DR) National Regulatory Agencies (NRA) with the riskbased categories of FDA and EMA as encouraged by the ICH. The FDA and EMA are considered reference authorities for many countries, as they are Stringent Authorities.