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

Clifford J Bailey

doi:10.1111/dom.13360

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

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	2057-2058
Journal	Diabetes, Obesity and Metabolism
Volume	20
Issue number	9
Early online date	13 May 2018
DOIs	https://doi.org/10.1111/dom.13360
Publication status	Published - Sept 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.

Access to Document

10.1111/dom.13360

European Medicines Agency: approval of new glucose-lowering medicines for type 2 diabetes
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.
Accepted author manuscript, 966 KB

Cite this

@article{84689c34cbcf4599b8b4e319ba0aa9bf,

title = "European Medicines Agency: approval of new glucose-lowering medicines for type 2 diabetes",

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.",

author = "Bailey, {Clifford J}",

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.",

year = "2018",

month = sep,

doi = "10.1111/dom.13360",

language = "English",

volume = "20",

pages = "2057--2058",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley-Blackwell",

number = "9",

}

TY - JOUR

T1 - European Medicines Agency: approval of new glucose-lowering medicines for type 2 diabetes

AU - Bailey, Clifford J

N1 - 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.

PY - 2018/9

Y1 - 2018/9

N2 - 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.

AB - 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.

UR - https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.13360

U2 - 10.1111/dom.13360

DO - 10.1111/dom.13360

M3 - Article

SN - 1462-8902

VL - 20

SP - 2057

EP - 2058

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 9

ER -

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

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this