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EMA’s ePI Roadmap
The European Medicines Agency (EMA) has released a draft roadmap for the implementation of electronic Product Information (ePI). This marks a major shift from traditional Word/PDF documents to a fully digitized, structured format designed to improve accessibility and...
Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
This document is based on questions frequently raised to EMA by sponsors during CTIS events such as Walk-in Clinics, Bitesize Talks, and through the EMA CTIS Service Desk. It serves as complementary document to the Sponsor Handbook, which is the main operational...
The new CTIS Sponsor Handbook (v6.2, March 2026)
The EMA Clinical Trials Information System (CTIS) Sponsor Handbook provides clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations...
New revision of the Q&A document on art. 10(a) interruption of supply published
Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards...
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