What is eCTD 4.0?
The level of regulatory efficiency is essential in the modern rapidly changing pharmaceutical environment. The most recent global standard aimed at simplifying drug submissions is Electronic Common Technical Document (eCTD) 4.0. It streamlines regulatory authority and pharmaceutical firm communication, management and tracking of submission content- providing greater efficiency, accuracy and global harmonization.
Overview of the Electronic Common Technical Document 4.0 Standard
eCTD 4.0 is an electronic submission format that is being developed by the International Council for Harmonisation (ICH) to serve pharmaceutical regulatory submissions. It supersedes the older eCTD v3.2.2, and provides a metadata-driven, document-oriented structure. This enables pharmaceutical firms to reuse records, trace submission lifecycle more precisely, and enable two-way communication with regulators. It is based on the HL7 Regulated Product Submission (RPS) standard to facilitate data congruence and regulatory uniformity across jurisdictions such as the FDA, EMA, PMDA, and Health Canada.
Prepare Your Regulatory Submissions for Electronic Common Technical Document 4.0 with Masuu Global
US FDA and PMDA in Japan are now voluntarily accepting eCTD 4.0, and other nations are actively advancing to do so. Keep up with the new implementation timelines of eCTD 4.0 so that your submissions are up to date.
Electronic Common Technical Document 4.0 is an international program aimed at improving the efficiency, accuracy and speed of reviewing pharmaceutical products by the regulatory authorities. With more regulatory authorities shifting to this new standard, the Electronic Common Technical Document 4.0 will be the standard format of regulatory submissions globally. Its ultimate aims are to simplify the submission processes, facilitate harmonious interactions between health authorities and sponsors and promote harmonization on a global scale.
At Masuu Global, we are dedicated to providing pharmaceutical firms with the best regulatory solutions. We are also on track to implement eCTD 4.0 in our submission and publish sites so that our customers remain at the forefront in the changing regulatory environment.