New UK Clinical Trials Regulation enters into force
The Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025 entered into force in the UK on 28 April 2026. The Regulations amend the existing Medicines for Human Ise (Clinical Trials) Regulations 2004. The purpose of the new Regulation is to protect trial participants, strengthen patient safety, and accelerate
CTIS New Sponsors’ FAQ
The EMA has published a new Frequently Asked Question (FAQ) document concerning the Clinical Trials Information System (CTIS) document. The purpose of the FAQ document is to help clinical trial sponsors use the CTIS more effectively by providing responses to the most frequently asked questions that trial sponsors may have when creating and submitting clinical trial applications through the CTIS.
The document is divided into
European Commission sets new clinical trial targets for the EU
The European Commission, the Heads of Medicines Agencies (HMA), and the EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition of making the EU a more attractive destination for clinical research and to improve timely access to innovative medicines for patients. The aim is that, in the coming five years:
EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.