(025) Improving the Quality of Drug Safety Review Reports: SFDA Experience

Background: Drug safety monitoring is essential for promoting patient safety in relation to medicine use and for safeguarding public health. However, one major challenge which was sometimes encountered is the substandard quality of drug safety review reports.

Objectives: For the pharmacovigilance processes to be optimized, we developed a detailed checklist that guides drug safety assessors to seek and examine all available evidence and improve the quality of comprehensive drug safety review reports.

Methods: Using a combined approach, we utilized an introspective and expert-guided method to develop a new framework for developing drug safety review reports. We reviewed past drug safety review reports to identify quality issues as well as frameworks by other regulatory bodies. Input was also gathered from pharmacovigilance and pharmacoepidemiology experts regarding best practices in writing drug safety review reports. All these were carefully reviewed and used to draft checklist items for comprehensive drug safety review reports.

Results: The checklist outlines 10 required items for drug safety review reports as well as a detailed description of each item. Key quality items highlighted include Executive Summary, Background/Epidemiology, Methodology and Search Results (it should encompass an adequate description of the methodology, use of search keywords, adoption of Medical Dictionary for Regulatory Activities (MedDRA) terminology, comprehensive systematic search, and adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines), Literature Evidence (should provide descriptions of study types ,objectives, methodology, and results interpretation, and identify major study limitations), Global and Local Cases Assessment (should cover the total number of cases retrieved and assessed with completeness score, patient demographics, assessment based on the World Health Organization (WHO) criteria, justification of chosen causality category, frequency of serious and fatal cases , and interpretation of the Information Component), comprehensive evaluation of Regulatory Submissions such as Periodic Safety Update Report , Screening of Other Regulatory Agencies’ Action and proper interpretation of Bradford Hill Criteria for Causality Assessment. Language proficiency and proper use of citation engines should all be ensured.

Conclusions: The checklist is designed to mitigate inconsistencies and improve the quality of drug safety review reports, which will ultimately contribute to making the most informed regulatory decisions and optimize the regulatory decision-making process within the drug safety section