AUTHOR=Shi Junnan , Chen Xianwen , Hu Hao , Ung Carolina Oi Lam 

TITLE=Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

JOURNAL=Frontiers in Public Health

VOLUME=Volume 11 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1172557

DOI=10.3389/fpubh.2023.1172557

ISSN=2296-2565

ABSTRACT=While many drug regulatory authorities (DRAs) around the world advocate to the concept of regulatory science (RS), the implementation approaches of RS vary according to the local needs and have not been systemically examined. This study aimed to systematically identified the evidence about how RS was developed and adopted by the selected DRAs, and analyzed and compared its implementation experiences under the guidance of an implementation science framework. Documentary analysis of government documents and a scoping literature review were conducted and data analysis was performed under the guidance of the PRECEDE-PROCEED Model. DRAs in the United States, European Union, Japan and China had officially launched RS initiatives and were therefore selected as the target countries. There is no common consensus on the definition of RS among the DRAs. However, the agencies shared the same goal of developing and adopting RS, which was to develop new tools, standards and guidelines that could improve the effectiveness and efficiency of the risk and benefit assessment to the regulated products. Each DRA had decided their own priority areas for RS development and thus set specific objectives which might be technology-based, process-based or product-based. To advance RS, considerable resources had been allocated for staff training, advancing information technology and laboratory infrastructure, and funding research projects. DRAs also took multifaceted approaches to expand scientific collaborations through public-private partnerships, research funding mechanisms and innovation network. Cross-DRAs communications were also reinforced through horizon scanning system and consortium to better inform and assist the regulatory process. The output measurements might be scientific publications, funded projects, DRAs interactions, and evaluation methods. Improved regulatory efficiency and transparency leading to benefits to public health, patient outcomes and translation of drug research and development as the key primary outcomes of RS development were anticipated but not yet clearly defined. The application of the implementation science framework is useful for conceptualizing and planning the development and adoption of RS for evidence-based regulatory decision-making. Continuous commitment to the RS development and regular review of the RS goals by the decision-makers are important for DRAs to meet the ever-changing scientific challenges in their regulatory decision-making process.