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

  • Global Perspectives
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Abstract

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.

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Author information

Authors and Affiliations

  1. Global Regulatory Affairs, Amgen Inc, Thousand Oaks, CA, USA

    Neal E. Storm DRSc, MS, MBA, RAC

  2. International Center For Regulatory Science (ICRS), School of Pharmacy, University of Southern California, 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089-9014, USA

    Neal E. Storm DRSc, MS, MBA, RAC & Frances J. Richmond BNSc, MSc, PhD

Authors
  1. Neal E. Storm DRSc, MS, MBA, RAC
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  2. Frances J. Richmond BNSc, MSc, PhD
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Corresponding author

Correspondence to Neal E. Storm DRSc, MS, MBA, RAC.

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Storm, N.E., Richmond, F.J. Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis. Ther Innov Regul Sci 49, 269–278 (2015). https://doi.org/10.1177/2168479014558276

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  • DOI: https://doi.org/10.1177/2168479014558276

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