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).
Overview of MoCRA 2022: Key Provisions and FDA Cosmetic Regulations
A significant increase in the U.S. was achieved through the introduction of several important provisions in the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The FDA is responsible for regulating cosmetics. Some key aspects of MoCRA include:
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 (release notes are also published).
FDA Adverse Event Reporting System (FAERS) Electronic Submissions:
To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Statement of Policy Intent: International Recognition of Medical Devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory bodies, while still retaining the authority to reject applications if the supporting evidence is deemed insufficient.