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).
Category: eCTD
Regulatory update EU eCTD Validation Criteria
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 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.