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Related Concept Videos

Drug Control Governance: Regulatory Bodies and Their Impact01:03

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
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Transcriptional regulators bind to specific cis-regulatory sequences in the DNA to regulate gene transcription. These cis-regulatory sequences are very short, usually less than ten nucleotide pairs in length. The short length means that there is a high probability of the exact same sequence randomly occurring throughout the genome.  Since regulators can also bind to groups of similar sequences, this further increases the chances of random binding. Transcriptional regulators form...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Expanding regulatory science: Regulatory complementarity and reliance.

Jackson K Mukonzo1, Helen Byomire Ndagije2, George Tsey Sabblah3

  • 1Department of Pharmacology & Therapeutics, Makerere University, College of Health Science, Kampala, Uganda.

Clinical and Translational Science
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Summary

Regulatory reliance is growing globally, but often overlooks insights from low- and middle-income countries (LMICs). Embracing "Regulatory Complementarity" can enhance global drug regulation by valuing diverse contextual knowledge.

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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.