Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations
Background Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon.Methods This...
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| Format: | Article |
| Language: | English |
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Kerman University of Medical Sciences
2023-12-01
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| Series: | International Journal of Health Policy and Management |
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| Online Access: | https://www.ijhpm.com/article_4515_52eb537e9aaec6fca614cafea4fd2889.pdf |
| _version_ | 1797206314649124864 |
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| author | Junnan Shi Xianwen Chen Hao Hu Carolina Oi Lam Ung |
| author_facet | Junnan Shi Xianwen Chen Hao Hu Carolina Oi Lam Ung |
| author_sort | Junnan Shi |
| collection | DOAJ |
| description | Background Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon.Methods This study employed an integrative and critical review of the literature and documents on benchmarking drug regulatory capacities identified from 6 databases and 5 websites of related organizations and government agencies in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.Results Forty-three studies and 6 documents about regulatory benchmarking published between 2005 and 2022 were included in this review. Five benchmarking assessment tools or programmes recommended or adopted by international organizations or government agencies had been identified, which collectively covered 12 major regulatory functions (4 at system level and 8 at operational level) involving 9 indicator categories and 382 sub-indicators. Benchmarking drug regulatory systems was reportedly employed at national, regional and international levels for either internal assessment (mostly on regulatory system establishment, drug review process and post marketing surveillance) or external evaluation (mostly on regulatory standards, drug review process and pharmacovigilance systems) to assess current status, monitor performance, determine major challenges, and inform actions for capacity building. Priority of actions in areas such as regulatory process, resources allocation, cooperation and communication, and stakeholder engagement have been suggested for strengthening drug regulatory systems. Nevertheless, the evidence about benchmarking in optimizing regulatory capacities remained underreported.Conclusion This integrative review depicted a framework for decision-makers about why and how benchmarking drug regulatory systems should be undertaken. For effective benchmarking, well-informed decisions about the goals, the scope, the choice of reference points, and benchmarking tools are essential to guide the implementation strategies. Further studies about the positive effects of regulatory benchmarking are warranted to engage continuous commitment to the practice. |
| first_indexed | 2024-04-24T09:05:03Z |
| format | Article |
| id | doaj.art-51872f969d1d4263ba4d57b1e135cbdc |
| institution | Directory Open Access Journal |
| issn | 2322-5939 |
| language | English |
| last_indexed | 2024-04-24T09:05:03Z |
| publishDate | 2023-12-01 |
| publisher | Kerman University of Medical Sciences |
| record_format | Article |
| series | International Journal of Health Policy and Management |
| spelling | doaj.art-51872f969d1d4263ba4d57b1e135cbdc2024-04-15T19:04:25ZengKerman University of Medical SciencesInternational Journal of Health Policy and Management2322-59392023-12-0112Issue 111510.34172/ijhpm.2023.81004515Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and RecommendationsJunnan Shi0Xianwen Chen1Hao Hu2Carolina Oi Lam Ung3State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, ChinaState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, ChinaState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, ChinaState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, ChinaBackground Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon.Methods This study employed an integrative and critical review of the literature and documents on benchmarking drug regulatory capacities identified from 6 databases and 5 websites of related organizations and government agencies in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.Results Forty-three studies and 6 documents about regulatory benchmarking published between 2005 and 2022 were included in this review. Five benchmarking assessment tools or programmes recommended or adopted by international organizations or government agencies had been identified, which collectively covered 12 major regulatory functions (4 at system level and 8 at operational level) involving 9 indicator categories and 382 sub-indicators. Benchmarking drug regulatory systems was reportedly employed at national, regional and international levels for either internal assessment (mostly on regulatory system establishment, drug review process and post marketing surveillance) or external evaluation (mostly on regulatory standards, drug review process and pharmacovigilance systems) to assess current status, monitor performance, determine major challenges, and inform actions for capacity building. Priority of actions in areas such as regulatory process, resources allocation, cooperation and communication, and stakeholder engagement have been suggested for strengthening drug regulatory systems. Nevertheless, the evidence about benchmarking in optimizing regulatory capacities remained underreported.Conclusion This integrative review depicted a framework for decision-makers about why and how benchmarking drug regulatory systems should be undertaken. For effective benchmarking, well-informed decisions about the goals, the scope, the choice of reference points, and benchmarking tools are essential to guide the implementation strategies. Further studies about the positive effects of regulatory benchmarking are warranted to engage continuous commitment to the practice.https://www.ijhpm.com/article_4515_52eb537e9aaec6fca614cafea4fd2889.pdfregulatory capacitycapacity buildingglobal benchmarking tooldrug regulatory systemsnational regulatory authorities |
| spellingShingle | Junnan Shi Xianwen Chen Hao Hu Carolina Oi Lam Ung Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations International Journal of Health Policy and Management regulatory capacity capacity building global benchmarking tool drug regulatory systems national regulatory authorities |
| title | Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations |
| title_full | Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations |
| title_fullStr | Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations |
| title_full_unstemmed | Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations |
| title_short | Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations |
| title_sort | benchmarking drug regulatory systems for capacity building an integrative review of tools practice and recommendations |
| topic | regulatory capacity capacity building global benchmarking tool drug regulatory systems national regulatory authorities |
| url | https://www.ijhpm.com/article_4515_52eb537e9aaec6fca614cafea4fd2889.pdf |
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