Global Postmarket Pharmacovigilance: A Generic Drug Perspective.

Abstract

Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic drug postmarket safety and surveillance methods adopted by regulatory agencies in different countries. The purpose of this research is to collect available information from a sample of international regulators with the overall goal of providing a general overview of each agency's decision-making processes for postmarket generic drug safety and surveillance. A structured four-part questionnaire of open-ended and multiple-choice questions along with a semi-structured interview were designed to elicit detailed information. Swissmedic, Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and the U.S. Food and Drug Administration (FDA) provided information. Detailed information from participating regulatory agencies demonstrated some similarities and differences in their postmarket generic drug pharmacovigilance approaches. This study examines each agency's scientific perspective to address generic drug safety issues, as well as to identify common barriers within decision-making processes, such as legislative restrictions and limited resources. Most agencies do not have specific processes that are unique to generic drug products. This exploratory study, through documenting common and unique approaches intends to create a greater awareness and to promote cross-collaboration between global regulatory agencies.