European Medicines Agency: approval of new glucose-lowering medicines for type 2 diabetes

Bailey, Clifford J (2018). European Medicines Agency: approval of new glucose-lowering medicines for type 2 diabetes. Diabetes, Obesity and Metabolism, 20 (9), pp. 2057-2058.

Abstract

Since 2005 all new glucose‐lowering medicines to be used in Europe have required approval by the European Medicines Agency (EMA) through a centralised procedure [1]. This involves assessment of a detailed file of data generated during the preclinical studies and phase 1‐3 clinical trials, along with the proposed product label. The file is subject to internal review and some aspects may also receive external review, giving rise to questions that are referred back to the sponsor and may lead to additional studies. The assessment is considered by the Committee for Medicinal Products for Human Use (CHMP) and if approval is recommended then a marketing authorisation is usually granted by the European Commission.

Publication DOI: https://doi.org/10.1111/dom.13360
Divisions: Life & Health Sciences > Biosciences
Life & Health Sciences
Additional Information: This is the peer reviewed version of the following article: Bailey, C. J. (2018), European Medicines Agency: approval of new glucose‐lowering medicines for type 2 diabetes. Diabetes Obes Metab. Accepted Author Manuscript., which has been published in final form at https://doi.org/10.1111/dom.13360.  This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.
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Related URLs: https://onlinel ... .1111/dom.13360 (Publisher URL)
Published Date: 2018-05-13
Published Online Date: 2018-05-13
Authors: Bailey, Clifford J ( 0000-0002-6998-6811)

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