Current Trends in Planning Preparation and Delivering Regulatory Submission Through Various Electronic Common Technical Document Software
Year: 2025
Type: article
Abstract: The pharmaceutical sector is growing more and more keen on the subject of Electronic Common Technical Documentation (eCTD). An "Electronic Common Technical Document" is a regulatory information transfer link for the pharmaceutical industry (eCTD). The option to submit an eCTD simultaneously with a paper submission (Common Technical Document) has been available to applicants since June 2003, when the eCTD Specification document is accepted at Step 4 by the International Conference on Harmonization Steering Committee. For both medication manufacturers and regulators, it is intended to make regulatory filings simpler and more effective. There are still variances across nations and even ICH areas when it comes to eCTD submission. Electronic submissions will offer uniformity, which will enable much better consistency for both businesses and regulators. It is crucial to create eCTD ready papers by using eCTD compliant templates while writing them. Document reformatting consumes a significant portion of time during the transformation from paper-based to electronic CTD submissions. If not done correctly, regulatory authorities may encounter various issues, which can affect compliance and delay the approval process. History of eCTD, advantages of implementation, difficulties with modules, risks associated with eCTD publication, and quality control are all covered in this article.
DOI: 10.37521/30104
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: bronze
Funder: JSS College of Pharmacy
OpenAlex ID: W4409141373