5 February 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 and FDA agree principles for trustworthy AI in medicines
14 January 2026
The European Medicines Agency and the U.S. Food and Drug Administration have jointly set out ten principles for good artificial intelligence practice across the medicines lifecycle. The principles provide high-level guidance on the use of AI in evidence generation and monitoring, from early research and clinical trials through to manufacturing and post-marketing safety oversight, supporting more consistent and reliable adoption of AI in regulatory contexts. Read more
EMA
EMA recommends over 100 new human medicines in 2025
15 January 2026
The European Medicines Agency has recommended 104 new human medicines for approval in 2025, including 38 containing a new active substance. Read more
EMA
EU sets out methodology for reviewing list of critical medicines
19 January 2026
A new methodology document explains how medicines are assessed for inclusion on, or removal from, the Union list of critical medicines, covering governance, criteria, and review timelines. The guidance also clarifies what information applicants must provide when requesting a review, supporting a more transparent and consistent process across the European Union. Read more
EMA
New Q&A clarifies use of Product Lifecycle Management documents
26 January 2026
A scientific questions-and-answers document sets out general principles for preparing, submitting, and evaluating Product Lifecycle Management (PLCM) documents. Applicable to all human medicines, the guidance aims to support consistent use of PLCM tools throughout a product’s lifecycle and streamline regulatory assessment. Read more
EC
SCHEER updates guidance on weight-of-evidence risk assessment
18 December 2025
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published a 2026 update to its memorandum on using the weight-of-evidence approach in risk assessment. The revised guidance replaces the 2018 version and aims to promote consistent, robust use of weight-of-evidence methods across EU bodies assessing risks to human health and the environment. Read more
EC
2024 report reviews compliance with EU paediatric medicines regulation
8 January 2026
The 2024 annual report on the paediatric medicines regulation summarises how the framework was applied during the year, including companies that benefited from the incentives and those found to be non-compliant. The overview supports transparency around how the regulation is functioning across the European Union and where enforcement action has been required. Read more
EC
EU publishes report on emerging health technologies for 2026 HTA planning
9 January 2026
A new report on emerging health technologies has been published to support planning under the EU Health Technology Assessment Regulation, focusing on medicines and medical devices expected to fall within scope in 2026. Requested by the HTA Coordination Group, the report helps inform preparation for joint clinical assessments while also fulfilling transparency obligations by publishing anonymised, aggregated, non-confidential information under the Regulation. Read more
EC
EU assessment sharpens focus on priority health threats
9 January 2026
The EU has published its first Comprehensive Health Threat Prioritisation Assessment under the Medical Countermeasures Strategy, identifying the most serious cross-border health threats requiring targeted action. The assessment supports coordinated EU-level planning to secure timely access to vaccines, therapeutics, diagnostics, and protective equipment through research, procurement, stockpiling, and distribution. Read more
HMA
EU introduces worksharing approach for ASMF assessments
7 january 2026
A new worksharing procedure has been established to harmonise the assessment of Active Substance Master Files and reduce update frequency and regulatory burden for authorities and companies. Led by the Working Group on Active Substance Master File Procedures, the approach introduces a central EU numbering system and a shared repository for ASMF assessment reports, supporting more efficient and consistent evaluations across the EU. Read more
HMA
FAST-EU pilot launches to speed up EU clinical trial assessments
21 january 2026
The FAST-EU pilot project started on 30 January 2026, introducing an expedited approach to the assessment of clinical trial applications across the EU. With a sponsor guide now available, the initiative aims to help developers better navigate the process and accelerate trial start-up timelines through more coordinated regulatory review. Read more
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