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 selected the most important regulatory updates from the past month.
EMA
EMA and Health Canada align clinical data publication through work-share initiative
20 April 2026
The EMA and Health Canada have introduced a voluntary work-share process to coordinate the review and publication of clinical data for human medicines. This new Q&A guidance outlines eligibility and applicant responsibilities, aiming to reduce duplication, harmonise timelines, and improve transparency in line with EMA Policy 0070. Read more
EMA
EMA pilots new pathway for breakthrough medical devices
28 April 2026
The EMA has launched a pilot programme to support the development of breakthrough medical devices through a new regulatory pathway in the EU. The initiative offers enhanced support, including priority scientific advice from expert panels, aiming to speed up patient access to highly innovative technologies while maintaining robust safety and performance standards. Read more
EMA
EMA establishes advisory group to strengthen vaccine confidence
29 April 2026
The EMA has created a new advisory group to address vaccine hesitancy and support efforts to improve public confidence in vaccines. Comprising over 20 European and international experts, the group will guide the Agency’s outreach and communication strategies. Read more
EC
EU update highlights national differences in MDR clinical study requirements
20 April 2026
A new overview of Member State-specific requirements under the EU Medical Device Regulation highlights variations in how countries manage clinical investigations and performance studies. The update covers authorisation processes, timelines, safety reporting, and modification rules, providing important insight for sponsors planning multi-country studies across the European Union. Read more
EC
EU updates manual on borderline and device classification rules
22 April 2026
An updated version (v5) of the manual on borderline and classification under the EU Medical Devices and In Vitro Diagnostic Regulations reflects agreements reached by Member States through the Borderline and Classification Working Group. The document provides further clarity on classification decisions and supports consistent interpretation across the European Union, particularly for complex or borderline products. Read more
HMA
CMDh reports progress on harmonising EU medicines procedures in 2025
3 April 2026
The CMDh has published its 2025 activity report, highlighting efforts to streamline regulatory processes across the EU. Key updates include improvements to variation procedures, lifecycle management, product information harmonisation, and pharmacovigilance coordination, supporting greater efficiency and consistency across Member States. Read more
HMA
CMDh sets strategic priorities in workplan to 2028
3 April 2026
The CMDh has shared its multi-annual workplan to 2028, outlining key priorities to address evolving regulatory challenges and opportunities. The plan reinforces the group’s role in harmonisation, procedural guidance, and resolving Member State disagreements, supporting a more coordinated and efficient EU regulatory network. Read more
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