Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis.

Background: The footprint of drug distribution is multinational, but the regulatory frameworks supporting drug development, review, and approval remain largely regional. As a result, industry faces regulatory standards that may be complementary, additive, or contradictory, resulting in global regulatory dissonance (GRD).

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.