TY - JOUR
T1 - Innovative diagnostic technologies
T2 - navigating regulatory frameworks through advances, challenges, and future prospects
AU - Rodriguez-Manzano, Jesus
AU - Subramaniam, Sumithra
AU - Uchea, Chibuzor
AU - Szostak-Lipowicz, Katarzyna M.
AU - Freeman, Jane
AU - Rauch, Marcus
AU - Tinto, Halidou
AU - Zar, Heather J.
AU - D'Alessandro, Umberto
AU - Holmes, Alison H.
AU - Awandare, Gordon A.
N1 - Publisher Copyright:
© 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2024/12
Y1 - 2024/12
N2 - Diagnostic tools are key to guiding patient management and informing public health policies to control infectious diseases. However, many diseases still do not have effective diagnostics and much of the global population faces restricted access to reliable, affordable testing. This limitation underscores the urgent need for innovation to enhance diagnostic availability and effectiveness. Developing diagnostics presents distinct challenges, especially for innovators and regulators. Unlike medicines, regulatory pathways for diagnostics are often less defined and more complex due to their diverse risk profiles and wide range of products. These challenges are amplified in low-income and middle-income countries, which often do not have regulatory frameworks for this specific purpose. In the UK, initiatives aim to support innovation by providing clearer regulatory pathways and ensuring that diagnostics are safe and effective. Regulators are also collaborating internationally to expedite diagnostics for high-need regions. Harmonised standards, regulatory frameworks, and approval processes are essential to ensure consistent quality and safety across regions and facilitate faster development and global access. This Series paper explores the regulatory challenges in infectious disease and antimicrobial resistance diagnostics, focusing on the UK's response and the broader global efforts to address these issues.
AB - Diagnostic tools are key to guiding patient management and informing public health policies to control infectious diseases. However, many diseases still do not have effective diagnostics and much of the global population faces restricted access to reliable, affordable testing. This limitation underscores the urgent need for innovation to enhance diagnostic availability and effectiveness. Developing diagnostics presents distinct challenges, especially for innovators and regulators. Unlike medicines, regulatory pathways for diagnostics are often less defined and more complex due to their diverse risk profiles and wide range of products. These challenges are amplified in low-income and middle-income countries, which often do not have regulatory frameworks for this specific purpose. In the UK, initiatives aim to support innovation by providing clearer regulatory pathways and ensuring that diagnostics are safe and effective. Regulators are also collaborating internationally to expedite diagnostics for high-need regions. Harmonised standards, regulatory frameworks, and approval processes are essential to ensure consistent quality and safety across regions and facilitate faster development and global access. This Series paper explores the regulatory challenges in infectious disease and antimicrobial resistance diagnostics, focusing on the UK's response and the broader global efforts to address these issues.
UR - http://www.scopus.com/inward/record.url?scp=85210119516&partnerID=8YFLogxK
U2 - 10.1016/S2589-7500(24)00242-5
DO - 10.1016/S2589-7500(24)00242-5
M3 - Review article
C2 - 39547914
AN - SCOPUS:85210119516
SN - 2589-7500
VL - 6
SP - e934-e943
JO - The Lancet Digital Health
JF - The Lancet Digital Health
IS - 12
ER -