METHODS: Global regulatory dissonance was explored through a case study of drug development (postmenopausal osteoporosis) using survey methodology.
RESULTS: In the feedback received, respondents generally agreed that GRD increases the complexity, timelines, and size of registration studies. Dissonant regulatory feedback on proposed labeling, applications, and benefit-risk assessments was also reported. Multiple causes of GRD were identified, including dissonant drug regulatory authority advice, guidelines, benefit-risk assessments, drug approval precedents, medical standards of care, and health technology assessments. Harmonization of guidelines, scientific advice, benefit-risk procedures, and expanded use of mutual recognition agreements were identified as mechanisms thought to reduce GRD.
CONCLUSIONS: The results suggest that global access to new drugs may be enhanced through a greater understanding of GRD.