Framework for identifying reference countries in drug safety evaluation: an application of the analytic hierarchy...

Effective monitoring of global drug safety information is increasingly important for public health. However, the large volume of global safety data, combined with variations in pharmaceutical systems and national regulatory contexts, poses challenges in prioritizing relevant information. To address this challenge, this study aimed to develop a set of criteria for selecting reference countries when evaluating foreign drug safety data.

Experts from academia and the pharmaceutical industry participated in focus group interviews (FGIs) to identify key factors for selecting reference countries. The Analytic Hierarchy Process (AHP) was then used to determine the relative importance of these factors. Additional FGIs were conducted to assess the validity of the resulting framework, including the relative weights of each criterion.

A total of 11 criteria were identified - six country-specific and five drug-specific. Among the country-specific criteria, 'countries officially being referenced' (weight = 0.374) and 'countries with strong pharmaceutical safety management' (0.256) were rated as most important. For drug-specific criteria, 'reliability of the report' (0.433) and 'accessibility of the report' (0.181) were prioritized. In contrast, criteria such as 'countries with advanced economies' (0.060) and 'drug's country of origin' (0.090) were considered less significant. Experts from both academia and industry generally supported the prioritization.

This study proposes a structured, evidence-based framework for referencing overseas pharmaceutical safety information. By assigning relative weights to country - and drug-specific criteria, the framework facilitates more consistent and efficient decision-making by national regulatory authorities, particularly in contexts where global safety data are extensive and pharmaceutical regulatory environments vary significantly. Given its basis in a regulatory environment that heavily relies on foreign safety data, the framework may be adapted for use in other countries with similar pharmacovigilance needs.