Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape

被引：2

作者：

Capone, Giacomo ^{[1
]}

Eriksson, Bjoern ^{[2
]}

Al, Monique ^{[3
]}

van Belkum, Stan ^{[3
]}

Broich, Karl ^{[4
]}

Lamas, Maria ^{[5
]}

Lunzer, Marianne ^{[6
]}

Nolan, Lorraine ^{[7
]}

Ester, Catriona ^{[1
]}

Burgos, Juan Garcia ^{[1
]}

Pioppo, Laura ^{[1
]}

Zanoletty, Ana ^{[1
]}

Arlett, Peter ^{[1
]}

机构：

[1] European Med Agcy, Amsterdam, Netherlands

[2] Lakemedelsverket, Uppsala, Sweden

[3] Cent Comm Res Involving Human Subjects, The Hague, Netherlands

[4] Bundesinst Arzneimittel & Med Prod, Bonn, Germany

[5] Agencia Espanola Medicamentos & Prod Sanitarios, Madrid, Spain

[6] AGES MEA, Vienna, Austria

[7] Hlth Prod Regulatory Author, Dublin, Ireland

来源：

NATURE REVIEWS DRUG DISCOVERY | 2024年 / 23卷 / 11期

关键词：

D O I：

10.1038/d41573-024-00085-5

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Accelerating Clinical Trials in the EU (ACT EU) is an initiative developed by the European Commission, Heads of Medicines Agencies and the European Medicines Agency to transform the clinical trials landscape in the European Union. It aims to foster regulatory, technological and process innovation to support better, faster and optimized clinical trials.

引用

页码：797 / 798

页数：2

共 50 条

[21] EU nations approve law to overhaul clinical trials
Watson, Rory
BMJ-BRITISH MEDICAL JOURNAL, 2013, 347
[22] British component of EU Clinical Trials Directive postponed
不详
R&D MAGAZINE, 2003, 45 (08): : 33 - 33
[23] EU directive on clinical trials penalizes small sponsors
Meldolesi, A
NATURE BIOTECHNOLOGY, 2003, 21 (08) : 838 - 838
[24] Drug clinical trials as a part of clinical pharmacology in the Czech Republic (EU)
Strnadova, V
Necas, J
CLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, 2004, 31 (11) : A231 - A232
[25] Navigating EU clinical trials: Adapting to a new era of regulations
Kromar, Stephanie
Kassas, Rana
JOURNAL OF CANCER POLICY, 2025, 43
[26] EU-PEARL: Changing the paradigm of clinical trials in Europe
Cash-Gibson, Lucinda
Pericas, J. M.
Spiertz, C.
de Ketterij, E. van
Molero, E.
Patalano, F.
Kalra, D.
Ussi, A.
Van Dessel, A.
Genesca, J.
EUROPEAN JOURNAL OF PUBLIC HEALTH, 2021, 31
[27] REGULATION (EU) NO 536/2014 ON CLINICAL TRIALS AND VULNERABLE GROUPS
Marino Hernandez, Eduardo L.
CUADERNOS DE BIOETICA, 2015, 26 (88): : 427 - 430
[28] Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU
Alfons Verbruggen
Heinz H. Coenen
Jean-Robert Deverre
Denis Guilloteau
Bengt Langstrom
Piero A. Salvadori
Christer Halldin
European Journal of Nuclear Medicine and Molecular Imaging, 2008, 35 : 2144 - 2151
[29] EU clinical trials directive: 0% inspiration, 100% perspiration?
不详
LANCET NEUROLOGY, 2004, 3 (06): : 321 - 321
[30] EU-PEARL: changing the paradigm of clinical trials in Europe
Cash-Gibson, L.
FEBS OPEN BIO, 2021, 11 : 71 - 72

← 1 2 3 4 5 →