Expanding regulatory science: Regulatory complementarity and reliance

Drug regulatory institutions, infrastructures, and systems are becoming increasingly interconnected across national boundaries and increasingly global in outlook. This process is reflected in the broadening and deepening application of the principles and practice of Regulatory Reliance, and parallel initiatives to strengthen the capacities of regulatory institutions in low- and middle-income countries (LMICs). Although these developments are important and constructive, they have tended to be framed in terms of the transfer of systems, knowledge, and skills from relatively mature regulatory agencies in high-income countries (HICs) to less-well-resourced regulatory agencies in LMICs. This framing recognizes and foregrounds the considerable practical challenges that many LMIC regulatory agencies face, but in doing so, also backgrounds and underestimates the significance of the different contextual insights that LMIC health researchers and regulators can bring to the regulatory deliberations of their HIC counterparts. This position paper argues that the systematic pursuit, identification, and sharing of these different contextual insights-a dimension of regulatory science that we term Regulatory Complementarity-can augment the current practice and goals of Regulatory Reliance, and further invigorate the emerging global regulatory ecosystem.

Automated summary

Drug regulatory institutions are increasingly interconnected globally, with efforts to strengthen capacities in low- and middle-income countries. However, there is a tendency to focus on transferring knowledge and skills from high-income countries to low-income countries, while overlooking the unique insights that low-income countries can bring to regulatory deliberations.