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 updates marketing authorisation assessment templates to improve efficiency
8 May 2026
The European Medicines Agency is updating its marketing authorisation assessment templates to reduce duplication and streamline evaluations. Following a pilot in which applicants pre-filled sections of D80 reports, the revised approach aims to improve consistency and efficiency in the preparation of interconnected assessment reports used during medicines authorisation. Read more
EMA
EMA monitors hantavirus outbreak
8 May 2026
The European Medicines Agency is actively monitoring an ongoing hantavirus outbreak associated with a cruise ship, working in coordination with other EU bodies. The activity highlights continued regulatory vigilance and cross-agency collaboration to assess potential public health risks and support an appropriate response. Read more
EMA
EU reports early progress towards 2030 clinical trial targets
20 May 2026
The EC, HMA, and EMA have published their first progress report on the EU’s 2030 clinical trial ambitions, highlighting early gains in multinational studies and recruitment speed. Between January and March 2026, 19 additional multinational clinical trials were authorised above the historical average, while 40.5% of trials recruited participants within 200 days of application submission, marking progress towards the EU’s targets to strengthen clinical research and improve timely access to innovative medicines. Read more
EMA
EMA recommends first oral GLP-1 treatment for weight management
22 May 2026
The European Medicines Agency has recommended extending the marketing authorisation for Wegovy (semaglutide) to include an oral formulation for weight management in the EU. Used alongside diet and physical activity, the tablets would be available for adults with obesity or those who are overweight with at least one weight-related comorbidity, marking the first oral GLP-1 receptor agonist developed for weight management. Read more
EMA
CHMP recommends eight new medicines and 13 indication extensions
22 May 2026
At its 18–21 May 2026 meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval and backed therapeutic indication extensions for 13 existing products. Read more
EMA
EMA marks 20 years of support for SMEs in medicines development
28 May 2026
A new report highlights the impact of the EMA’s SME Regulation since its introduction in 2005, showing how tailored guidance, scientific advice, regulatory support, and fee incentives have helped thousands of small and medium-sized enterprises bring medicines to market. The initiative has played a key role in fostering innovation and supporting the development of medicines that benefit public and animal health across the EU. Read more
EMA
EMA considers updating guidance on treatments for nicotine dependence
29 May 2026
The European Medicines Agency has published a concept paper proposing revisions to its guideline on the development of medicinal products for smoking cessation. The update would broaden the scope to address dependence on newer tobacco-free nicotine products, such as e-cigarettes and oral nicotine products, reflecting changing patterns of nicotine use and growing concerns about addiction among adolescents and young adults. Read more
EC
Survey tracks medical device certifications and applications in the EU
8 May 2026
An updated survey of notified bodies provides insight into medical device certifications and applications as part of an EU study monitoring device availability under the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. Commissioned by DG SANTE through HaDEA, the project gathers stakeholder perspectives to assess market availability and regulatory impact, supporting oversight during implementation through to June 2026. Read more
EC
EU launches Global Health Resilience Initiative to strengthen health security
13 May 2026
The European Commission has introduced a new Global Health Resilience Initiative to improve Europe’s ability to respond rapidly to global health threats and crises. The initiative sets a strategic framework for future EU action, strengthening international cooperation, supporting health sovereignty in partner countries, and reinforcing Europe’s resilience, competitiveness, and preparedness in an interconnected world. Read more
EC
New FAQ clarifies publication of Joint Clinical Assessment reports
18 May 2026
New frequently asked questions have been published to clarify how Joint Clinical Assessment reports are published under the EU Health Technology Assessment Regulation. The document provides practical explanations for stakeholders on the application of Regulation (EU) 2021/2282, supporting greater transparency and understanding of publication requirements while noting that formal interpretation of EU law remains the responsibility of the Court of Justice of the European Union. Read more
EC
Commission welcomes agreement on Critical Medicines Act to strengthen supply resilience
20 May 2026
The European Commission has welcomed political agreement between the Council and European Parliament on the Critical Medicines Act, describing it as a major step towards improving the resilience of Europe’s medicines supply. The legislation aims to help prevent shortages and strengthen the security of supply of critical medicines across the EU, reinforcing preparedness within the health sector. Read more
EC
Commission publishes analysis supporting proposed Biotech Act
27 May 2026
The European Commission has released the analysis underpinning its proposed Biotech Act, outlining the expected impact of measures designed to strengthen Europe’s biotechnology sector. Drawing on evidence, stakeholder input, and supporting studies, the assessment highlights opportunities to simplify regulation, reduce administrative burden, and enhance competitiveness while maintaining high standards of safety and public health protection. Read more
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!