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Clinical and Translational Science
Article . 2023 . Peer-reviewed
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Expanding regulatory science: Regulatory complementarity and reliance

Authors: Jackson K. Mukonzo; Helen Byomire Ndagije; George Tsey Sabblah; Wangui Mathenge; David A. Price; Thaddeus H. Grasela;

Expanding regulatory science: Regulatory complementarity and reliance

Abstract

AbstractDrug 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.

Keywords

Humans, Drug and Narcotic Control, Therapeutics. Pharmacology, RM1-950, Position Paper, Public aspects of medicine, RA1-1270, Developing Countries

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    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
8
Top 10%
Top 10%
Top 10%
Green
gold