📆 On 9 September 2026, the European Medicines Agency (EMA) published Version 1.15 of the document Electronic submission of Article 57(2) data Questions & Answers (Q&As) Version 1.15

On 1 September 2026, the European Medicines Agency issued practical guidance on the submission of electronic product information, or ePI, for centrally authorised medicinal products. The agency noted that submitting ePI is voluntary until the general pharmaceutical...

Considerations for a harmonised approach for handling changes arising from the transition to EU MDR and IVDR Looking at the impact on the Middle East and Africa (MEA) region, where CE marking serves as a major regulatory reference supporting domestic registrations,...

This document provides a report on the status of implementation of all IMDRF technical documents as self-identified by IMDRF members as of the date of publication. In addition to overseeing IMDRF documents, the IMDRF Management Committee also oversees documents...