Sarcouncil Journal of Public Administration and Management
Sarcouncil Journal of Public Administration and Management
An Open access peer reviewed international Journal
Publication Frequency-Bi-Monthly
Publisher Name-SARC Publisher
ISSN Online- 2945-3712
Country of origin-PHILIPPINES
Language- Multilingual
Keywords
- Public Administration, Public Management, Human Resource Management, Organizational Theory, Ethics in Public Administration, Policy Analysis, Public Budgeting, Public Ethics, Government Policy, Administrative Theory, Administrative History
Editors
Dr Hazim Abdul-Rahman
Associate Editor
Sarcouncil Journal of Applied Sciences
Entessar Al Jbawi
Associate Editor
Sarcouncil Journal of Multidisciplinary
Rishabh Rajesh Shanbhag
Associate Editor
Sarcouncil Journal of Engineering and Computer Sciences
Dr Md. Rezowan ur Rahman
Associate Editor
Sarcouncil Journal of Biomedical Sciences
Dr Ifeoma Christy
Associate Editor
Sarcouncil Journal of Entrepreneurship And Business Management
eCTD 4.0 Adoption Trends and their Impact on Pharma Regulatory Operations
Keywords: eCTD 4.0; electronic submissions; regulatory compliance; regulatory operations; regulatory submissions.
Abstract: The adoption of Electronic Common Technical Document version 4.0 (eCTD 4.0) marks a pivotal shift in pharmaceutical regulatory submissions. Designed by the ICH, eCTD 4.0 enhances interoperability, data structuring, and communication efficiency. This review examines global trends in eCTD 4.0 implementation, its impact on submission processes, and the transformation from version 3.2. Key challenges such as system integration, training, and global harmonization are evaluated, alongside the opportunities for automation, agile lifecycle management, and improved data traceability across regulatory jurisdictions.
Author
- Deepaben Bhavsar
- Northeastern University- Boston MA USA