28 August 2025
From the European Medicines Agency’s (EMA) newsfeed, Arex Advisor has rounded up a selection of highlights from July to August 2025.
Clinical Trials Regulation: progress on implementation
26 August 2025
A new report on the authorisation of clinical trials in the European Union (EU) and European Economic Area (EEA) has been published. A total of 11,752 clinical trial applications have been submitted since the launch of CTIS. At the time when the report is generated, more than 5,810 initial clinical trials are ongoing in EU/EEA under the CTR. The therapeutic area mostly investigated is Neoplasms (Tumour). Read more
EU Commission maintains use of titanium dioxide in medicines
20 August 2025
The European Commission has confirmed that titanium dioxide will remain permitted in medicines, despite its ban as a food additive. A new EMA analysis found that available alternatives are not yet adequate to guarantee safety, efficacy, and quality, and that a ban would risk significant shortages of medicines across the EU. Titanium dioxide is currently used in around 91,000 human medicines and 1,600 veterinary medicines, primarily to provide consistent colouring, protect sensitive ingredients from light, and preserve product quality throughout shelf life. Read EMA’s feedback
New injection for prevention of HIV infection in the EU and worldwide
26 July 2025
The EMA has recommended EU approval of Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in adults and adolescents at high risk. The injectable treatment, given only twice a year, is expected to improve uptake and adherence compared with daily oral options. Read more
EMA backs eco-friendly propellant in an inhaled medicine
25 July 2025
The EMA has recommended switching the propellant in Trixeo Aerosphere and its duplicate Riltrava Aerosphere to a low global warming potential alternative. The new formulation reduces climate impact by around 1,000-fold while maintaining comparable physical properties. Read more
IRIS guide for applicants updated
18 July 2025
The latest IRIS guide explains how applicants can use the EMA’s IRIS platform to prepare, submit, and manage applications and data for a wide range of scientific and regulatory procedures. These include orphan designation, scientific advice, PRIME, inspections, parallel distribution, and product lifecycle management activities such as variations, renewals, PSURs, referrals, and post-authorisation measures. The guide also clarifies access roles for parallel distribution submissions and outlines how IRIS links to electronic application forms and dossiers submitted via the eSubmission Gateway. Read the guide
Pre-authorisation procedural advice updates
15 July 2025
The EMA has updated its pre-authorisation procedural advice for centrally authorised medicines. Changes include revised guidance on Paediatric Use Marketing Authorisation (PUMA) applications and on handling duplicate applications, updated requirements for orphan and paediatric dossier content, and clarifications to the assessment process. EMA post-authorisation procedural advice for users of the centralised procedure
Post-authorisation procedural advice updates
15 July 2025
EMA has revised its post-authorisation procedural advice for centrally authorised medicines. Updates include clarifications on grouping and submission requirements for Type IA variations, new guidance in Type II variations on adding non-orphan indications and on the process for removal of an orphan designation, and revised explanations on grouping of variations to ensure consistency with regulatory requirements. EMA post-authorisation procedural advice for users of the centralised procedure
EMA to revise guidance on Alzheimer’s drug trials
14 July 2025
The EMA plans to update its guideline on clinical investigations for Alzheimer’s disease, reflecting recent approvals and lessons from marketing applications for early-stage treatments. A draft revision is expected for public consultation by Q4 2026. Read the concept paper
EMA reviews AI and machine learning across medicines lifecycle
9 July 2025
The EMA has published a horizon scanning report on applications of artificial intelligence and machine learning in medicines development, covering drug discovery, clinical trials, manufacturing, and post-authorisation monitoring. The report highlights opportunities such as faster drug screening, personalised treatments, and improved pharmacovigilance, while noting challenges around data quality, transparency, regulatory acceptance, and patient privacy. Read the horizon scanning report
Rabbit Pyrogen Test phased out in Ph. Eur. from 1 July 2025
The EMA has confirmed that the Rabbit Pyrogen Test will be fully removed from the European Pharmacopoeia, with revised texts published in Supplement 11.8 and implemented from 1 July 2025. A new chapter, 5.1.13 Pyrogenicity, provides guidance on selecting appropriate in vitro alternatives based on risk assessment. Marketing Authorisation Holders are required to update their dossiers accordingly, as Ph. Eur. monographs are legally binding under EU law. Chapter 2.6.8 will be permanently deleted in January 2026. Read more
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!
