8 April 2026
From the regulatory newsfeeds of the European Medicines Agency’s (EMA), the European Commission (EC) and the Heads of Medicine Agencies (HMA), Arex Advisor has rounded up a selection of highlights from the past month.
EMA
EMA drafts guidance for microbiome-based medicines development
2 March 2026
The EMA has published a draft concept paper to support development of guidance on the non-clinical evaluation of microbiome-based medicinal products. The planned reflection paper will address specific considerations for these products and promote a harmonised approach across the EU for clinical trials and marketing authorisation applications under existing pharmaceutical legislation. Read more
EMA
EMA reports on orphan medicines incentives in 2025
3 March 2026
The EMA has published its 2025 report on the use of the special contribution for orphan medicinal products, highlighting continued activity in this area. A total of 211 applications for orphan designation were submitted, including 15% for advanced therapy medicinal products, underlining ongoing innovation in treatments for rare diseases. Read more
EMA
ACT EU proposes guidance for trials during public health emergencies
5 March 2026
The Accelerating Clinical Trials in the EU (ACT EU) initiative has published draft guidance on how clinical trials should be designed and conducted during public health emergencies. Open for stakeholder consultation, the guidance aims to support sponsors and trial stakeholders in maintaining robust, efficient studies under crisis conditions while ensuring regulatory compliance. Read more
EMA
EU sets out implementation approach for ICH E2D(R1) safety reporting guideline
6 March 2026
The European Medicines Agency has published guidance on how to implement the ICH E2D(R1) guideline on post-authorisation safety data within the EU. In order to allow MAHs to update their processes accordingly, an additional 6-month transition period
is permitted up to 18 September 2026. Read more
EMA
EU network advances strategy for data and AI in medicines regulation
9 March 2026
The HMA/EMA Network Data Steering Group is driving a strategic approach to improve data interoperability, enhance access to evidence, and support the use of artificial intelligence across the EU regulatory system. This document gives insight to how HMA/EMA aims to implement AI in the regulatory framework. Read more
EMA
Guidance clarifies GMP requirements for 3D-printed medicines
24 March 2026
A new Q&A document outlines quality and Good Manufacturing Practice expectations for the use of 3D printing (additive manufacturing) in producing solid oral dosage forms. The guidance highlights key considerations specific to 3DP while emphasising the need to align with existing EU GMP and quality frameworks, supporting the safe adoption of innovative manufacturing technologies. Read more
EMA
CTIS updates sponsor guidance with new FAQ document
26 March 2026
A new Frequently Asked Questions document has been published for the sponsor workspace within the Clinical Trial Information System (CTIS). The resource provides practical clarifications to help sponsors navigate system functionalities and regulatory requirements. Read more
EMA
EMA considers streamlined clinical approach for biosimilars
27 March 2026
The European Medicines Agency is assessing a tailored clinical development approach for biosimilar medicines, aiming to optimise requirements while maintaining EU safety standards. The reflection paper discusses how scientific experience and technological advances could reduce the need for extensive clinical data, supporting more efficient development and approval of biosimilars in the European Union. Read more
EMA
EU sets data quality standards for real-world data in regulation
27 March 2026
A new framework outlines how real-world data should be assessed and used within EU medicines regulation, building on the European Medicines Regulatory Network Data Quality Framework endorsed by the CHMP. The guidance defines key principles, concepts, and methods to ensure data quality, supporting more reliable use of real-world evidence in regulatory decision-making. Read more
EMA
EMA explores virtual control groups to reduce animal testing
31 March 2026
The European Medicines Agency’s human medicines committee (CHMP) is consulting on a novel methodology that replaces traditional animal control groups with virtual control groups in certain preclinical studies. If qualified, the approach could reduce animal use while remaining scientifically valid for regulatory submissions, marking a step forward in more ethical and innovative medicines development. Read more
HMA
EMA explores virtual control groups to reduce animal testing
4 March 2026
CMDh has released its 2025 statistics covering new applications, variations, referrals, and paediatric worksharing procedures. Read more
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