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

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Pages (from-to)2057-2058
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number9
Early online date13 May 2018
DOIs
Publication statusE-pub ahead of print - 13 May 2018

Bibliographical note

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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