Category: eCTD

What is Electronic Common Technical Document (eCTD)? Regulatory submissions are an important aspect of drug development and approval in the pharmaceutical industry. Electronic Common Technical Document (eCTD) has been developed to standardize and simplify the process of providing information to regulatory bodies. The eCTD is an internationally recognized format designed specifically to improve the submission,… Continue reading What is Electronic Common Technical Document (eCTD)

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… Continue reading What is eCTD 4.0?

EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP) The European Medicines Agency (EMA) has officially launched Step 2 of the eCTD v4.0 Technical Pilot, focused on Centrally Authorised Products (CAP). This phase invites a limited number of Marketing Authorisation Holders (MAHs) to participate based on readiness and alignment with… Continue reading EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP)

Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization The Kuwait Ministry of Health (Kuwait MOH) has made an important leap forward in the pharmaceutical regulatory landscape by transitioning from the Common Technical Document (CTD) format to the Electronic Common Technical Document (eCTD). This move aims to streamline the submission process for new… Continue reading Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization

AU-TGA eCTD Submission Updates: TGA has announced updates to Module 1 & Regional Information to the specifications and technical validation criteria transitioning from eCTD AU Module-1 v3.1 to v3.2.

eCTD IMPLEMENTATION IN TUNISIA The electronic Common Technical Document (eCTD) system for drug submissions is being implemented by Tunisia’s National Agency for Medicines and Health Products (ANMPS). The regulatory process for pharmaceutical products will be digitized starting in January 2025 with the transition to online submissions (eSubmission).

Updated EU M1 eCTD Specification   The EU eCTD Module 1 Specification has been updated to v3.1. EU M1 eCTD Specification v3.1 – Updated Guidelines: Release notes with practical information on changes are provided below. There are also changes to the DTD in this version (version 3.1), and the validation criteria was updated to v8.0… Continue reading Regulatory update EU eCTD Validation Criteria

SAHPRA eCTD Submission Updates SAHPRA eCTD Portal Launch: Beginning October 1, 2024, SAHPRA mandates all applications to be submitted via its eCTD Portal. Through this portal, applicants can register, upload content, and manage submission sequences. Detailed instructions are provided in the SAHPRA eCTD Portal Process Guide.