{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T14:27:44Z","timestamp":1762957664854,"version":"3.41.2"},"reference-count":9,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T00:00:00Z","timestamp":1744329600000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Evaluation Clinical Practice"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The Saudi Food and Drug Authority (SFDA) plays a pivotal role in safeguarding public health through robust pharmacovigilance. Since establishing its signal detection section in 2015, SFDA has implemented a comprehensive framework to monitor and evaluate drug safety through proactive data collection, advanced analytical methods, and international collaborations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To provide a comprehensive analysis of the current practices in signal detection at SFDA, assess the effectiveness of its regulatory framework, in\u2010house priority system, active surveillance programme, and global collaborations, and to offer recommendations for future enhancements in pharmacovigilance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A scientific review was conducted using publicly available literature, official SFDA guidelines, and internal reports. The evaluation focused on the regulatory mandate, data collection methodologies, signal generation processes (including weekly scanning of diverse sources), case validation, and the integration of advanced statistical techniques. Special emphasis was given to the in\u2010house priority algorithm, active surveillance initiatives, and collaborative efforts with international bodies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The review highlights that SFDA's robust regulatory framework and innovative in\u2010house priority algorithm have enhanced the efficiency of signal detection. The active surveillance programme has significantly increased the capacity for real\u2010time monitoring, while global collaborations have facilitated knowledge exchange and harmonised methodologies. However, challenges persist regarding data quality, resource allocation, and the need for continuous training and improved communication among stakeholders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>SFDA's signal detection system effectively contributes to drug safety in Saudi Arabia by combining rigorous regulatory practices with innovative analytical methods and international cooperation. Addressing current challenges through advanced technologies, enhanced resource allocation, and strengthened stakeholder communication is recommended to further improve pharmacovigilance practices and ensure public health protection.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jep.70062","type":"journal-article","created":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T11:31:14Z","timestamp":1744371074000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Signal Detection at SFDA: A Comprehensive Analysis of Current Practices and Future Directions"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-5635-9474","authenticated-orcid":false,"given":"Mohammed I.","family":"Fouda","sequence":"first","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdulaziz","family":"Alakeel","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roaa M.","family":"Alamri","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mobarak S.","family":"Al Shahrani","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali Y.","family":"Al Shahrani","sequence":"additional","affiliation":[{"name":"Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,4,11]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"\u201cPharmacovigilance \u201d World Health Organization accessed June 1 2023 https:\/\/www.who.int\/teams\/regulation-prequalification\/regulation-and-safety\/pharmacovigilance#:~:text=Pharmacovigilance%20is%20the%20science%20and they%20are%20authorized%20for%20use."},{"key":"e_1_2_11_3_1","unstructured":"\u201cUppsala Monitoring Centre \u201dUppsala Monitoring Centre accessed May 31 2023 https:\/\/who-umc.org\/."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ailsci.2021.100005"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200730070-00005"},{"key":"e_1_2_11_6_1","unstructured":"Saudi Food and Drug Authority Guideline on Good Pharmacovigilance Practices (GVP)2023 https:\/\/sfda.gov.sa\/en\/regulations\/79225."},{"key":"e_1_2_11_7_1","unstructured":"Pharmacovigilance WHO Pharmaceuticals Newsletter \u2010 N\u00b05 2017 www.who.int.https:\/\/www.who.int\/publications\/i\/item\/WPN-2017-05."},{"key":"e_1_2_11_8_1","unstructured":"Pharmacovigilance WHO Pharmaceuticals Newsletter \u2010 N\u00b01 2022 www.who.int.https:\/\/www.who.int\/publications\/i\/item\/9789240042452."},{"key":"e_1_2_11_9_1","unstructured":"Pharmacovigilance WHO Pharmaceuticals Newsletter \u2010 N\u00b02 2022 www.who.int.https:\/\/www.who.int\/publications\/i\/item\/9789240053083."},{"key":"e_1_2_11_10_1","unstructured":"DSRU The IWG on New Developments in Pharmacovigilance | DSRU Blog 2023 https:\/\/www.dsru.org\/blog\/the-dsru-international-working-group-on-new-developments-in-pharmacovigilance\/."}],"container-title":["Journal of Evaluation in Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jep.70062","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T14:28:55Z","timestamp":1745850535000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jep.70062"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":9,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1111\/jep.70062"],"URL":"https:\/\/doi.org\/10.1111\/jep.70062","archive":["Portico"],"relation":{},"ISSN":["1356-1294","1365-2753"],"issn-type":[{"type":"print","value":"1356-1294"},{"type":"electronic","value":"1365-2753"}],"subject":[],"published":{"date-parts":[[2025,4]]},"assertion":[{"value":"2024-01-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70062"}}