Therapeutic innovation & regulatory science · 2015
Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis.
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Storm Neal E, Richmond Frances J
Аннотация
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.
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.