RBI Tool

Evaluating the public health risks and benefits of the medicines on the market is often challenging for national medicines regulatory authorities (NMRAs) in low- and middle-income countries (LMICs). Partly due to their limited experienced human resources and budgetary constraints. The application of risk-based inspection approaches in regulatory practices offers an opportunity to identify and prevent infiltration of substandard and falsified pharmaceutical products into the legal market. The risk-based inspection of facilities in the distribution chains/channels by the NMRA’s contributes to the efforts towards establishing effective, affordable, and sustainable distribution chains.
Once the legally authorized products are authorized to be placed on the market, it is required to regulate the quality of product as advocated by national and international standards and guidance’s by performing active and/or ad hoc regulatory inspections throughout the distribution chains to monitor and prevent the infiltration of substandard and falsified medicines into the supply chains. These activities entail inspections of facilities involved in the procurement, supply, distribution and storage of medicines to inform regulatory decisions to support public health goals/initiatives and enforce compliance with regulatory requirements including the good practices (GxPs). These include good pharmaceutical procurement practices (GPProP), good storage practices (GSP) and good distribution practices (GSDP)., and good pharmacy practices (GPP) and dispensing practices (GDispP). In the face of limited resources, country MRAs must direct the available resources to address the challenges that present the highest risk to their public health, instead of spreading resources too thin and having minimal impact.