{Reference Type}: Journal Article
{Title}: Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis.
{Author}: Storm NE;Richmond FJ;
{Journal}: Ther Innov Regul Sci
{Volume}: 49
{Issue}: 2
{Year}: Mar 2015
{Factor}: 1.337
{DOI}: 10.1177/2168479014558276
{Abstract}: <B>BACKGROUND: </B>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).<BR><B>METHODS: </B>Global regulatory dissonance was explored through a case study of drug development (postmenopausal osteoporosis) using survey methodology.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>The results suggest that global access to new drugs may be enhanced through a greater understanding of GRD.