Strong Regulation of Medical Products: Cornerstone of Public Health and Regional Health Security

Abstract

National regulatory agencies (NRAs) are the gatekeepers of the supply chain of medical products such as pharmaceuticals and medical devices. It is through registration with an NRA that a manufacturer brings products to market. Post marketing surveillance of how those products perform and impact patient safety—including how quality is maintained in storage and distribution, and adverse events associated with their use—also falls under the agency’s remit, as does inspection of manufacturing facilities and regulation of product promotion and advertising. At the same time, the value chain for medical products is becoming increasingly globalized. In pharmaceutical manufacturing, for example, active ingredients may be sourced from multiple countries for medicines production in another, before being globally distributed. A weakness in one part of the supply chain can have adverse consequences for patients thousands of miles away.