Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines-Reference-Cited by-同舟云学术

Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines

Published:2024-05-12 Issue:5 Volume:58 Page:845-854
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Singh Rominder^ORCID,Wang William,Chakravarty Aloka,Wang Jun,Uyama Yoshiaki

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s43441-024-00639-0.pdf

Reference32 articles.

1. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. General principles for planning and design of multi-regional clinical trials E17 https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116pdf Date: Nov 16, 2017; Date accessed: April 28, 2023.

2. ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). 2017. ICH E17 Training Module.

3. The International Council for Harmonisation of Technical Requirements. for Pharmaceuticals for Human Use Ethnic factors in the acceptability of foreign clinical data E5 (R1). https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf Date: Feb 5, 1998; Date accessed: April 28, 2023.

4. European Federation of Pharmaceutical Industries and Associations (EFPIA), implementation of the ICH E17 guideline on planning and design of multi-regional clinical trials in international markets. 2021; https://www.efpia.eu/media/636586/efpia-ich-e17-advocacy-toolkit_dec-2021.pdf.

5. Japan Pharmaceutical Manufacturers Association (JPMA). Drug Evaluation From Now On What’s the value of local data in the global clinical data package? July 2022; https://www.jpma.or.jp/english/reports/drug_evaluation_committee/dsduth00000004zz-att/DS_202212_e17.pdf.