Expanding regulatory science: Regulatory complementarity and reliance

Area of Science:

• Regulatory Science
• Global Health Policy
• Drug Regulation

Background:

• Global drug regulatory systems are increasingly interconnected, fostering international collaboration.
• Regulatory Reliance initiatives aim to strengthen regulatory capacities, particularly in low- and middle-income countries (LMICs).
• Current frameworks often focus on knowledge transfer from high-income countries (HICs) to LMICs.

Purpose of the Study:

• To challenge the unidirectional knowledge transfer model in global drug regulation.
• To introduce and advocate for 'Regulatory Complementarity' as a vital dimension of regulatory science.
• To highlight the value of contextual insights from LMIC health researchers and regulators.

Main Methods:

• This is a position paper, presenting a conceptual argument.
• It analyzes the current framing of Regulatory Reliance and capacity-building initiatives.
• It proposes a new framework, 'Regulatory Complementarity', for enhancing global regulatory science.

Main Results:

• The current framing of Regulatory Reliance may underestimate the unique contributions of LMIC regulators.
• Systematic identification and sharing of diverse contextual insights can enrich regulatory deliberations.
• Regulatory Complementarity offers a pathway to a more robust and inclusive global regulatory ecosystem.

Conclusions:

• Valuing and integrating LMIC perspectives through Regulatory Complementarity can significantly augment global drug regulation.
• This approach moves beyond simple knowledge transfer to foster a truly collaborative and enriched global regulatory environment.
• Regulatory Complementarity is essential for the future of effective and equitable global drug regulation.