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Covering Regulatory Oversight, Basel III, EUDAMED, European Parliament, Cybersecurity. Explore key EU developments on Regulatory Oversight, Basel III, EUDAMED medical device rules, European Parliament legislative activity, and emerging Cybersecurity threats. Stay informed on critical regulatory shifts shaping multiple sectors.
Regulatory news, updates, and insights for countries in the EU presented by the Carver Agents team
Welcome to Carver's European Union Regulatory Updates for March 29, 2026.
The European Union continues to strengthen its regulatory framework across multiple sectors. First, the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion recommending marketing authorisation for Joenja, an immunostimulant targeting activated phosphoinositide 3-kinase delta syndrome, or APDS. Joenja is intended for patients aged 12 years and older weighing at least 45 kilograms. This marketing authorisation is granted under exceptional circumstances with specific obligations subject to annual review. Treatment initiation must be conducted by physicians experienced in primary immune deficiencies. Detailed product characteristics will be published following European Commission authorisation.
In medical device regulation, the European Union mandates the use of key EUDAMED modules starting May 28, 2026. Economic operators must complete registration in the Actor module before this date. Devices placed on the market on or after May 28, 2026, must be registered using the UDI or Device Registration module prior to first market placement. Legacy devices placed before May 28, 2026, must be registered by November 28, 2026. The mandatory use of Notified Bodies and Certificates, as well as Market Surveillance modules, will also commence on May 28, 2026, with specified transition periods for some modules. This update aims to improve transparency and regulatory oversight within the European Union’s medical device sector.
The European Union’s Payment Services Providers, or PSPs, will be subject to new Implementing Technical Standards under the Single Euro Payments Area Regulation. These standards require PSPs to report uniform data on credit transfers, charges, and rejected transactions to National Competent Authorities. Reporting must include the number and value of credit transfers and instant credit transfers, broken down by charge status, customer type, transaction nature—whether national or cross-border—and payment initiation method. Separate reporting templates will apply for euro and non-euro currency PSPs. This measure supports consistent data collection and regulatory oversight across the European Union.
On the pharmaceutical regulatory front, the Pharmaceutical Committee for Working Parties, or PCWP and HCPWP, held a joint meeting on March 27, 2026. Discussions focused on updates to pharmaceutical legislation implementation and the European Health Data Space. Stakeholders were encouraged to engage with young patients, consumers, and healthcare professionals. Monitoring of vaccine confidence initiatives was also emphasized.
The Working Party on Atomic Questions convened on March 27, 2026, addressing nuclear safety issues within the European Union and associated regions. The agenda included updates on nuclear safety in Ukraine and the Middle East, as well as reflections on draft European Parliament legislative resolutions dated March 3, 2026. Participants reviewed Ignalina and INSC-D regulations and prepared for the 2026 Convention on Nuclear Safety review meeting.
Turning to pharmacovigilance in France, the French National Agency for the Safety of Medicines and Health Products, or ANSM, continues surveillance of adverse effects related to the Chikungunya vaccine Ixchiq. Updated safety data have led to revisions in the vaccine’s product characteristics and patient information leaflets. New contraindications include risks of encephalopathy, encephalitis, and aseptic meningitis, particularly in elderly and young patients without comorbidities. Healthcare professionals are reminded to adhere strictly to contraindications for immunodeficient or immunosuppressed patients and to report adverse effects through regional pharmacovigilance centers.
In cybersecurity, France’s CERTFR bulletin number 2026-ACT-012, published on March 23, 2026, reports multiple critical vulnerabilities in various software products. The bulletin highlights a surge in targeted phishing attacks on instant messaging accounts of political and administrative figures. Stakeholders are urged to implement corrective actions promptly, refer to vendor advisories for patches and updates, and monitor linked devices on messaging accounts to detect unauthorized access.
Finally, the European Medicines Agency announced the withdrawal of the marketing authorisation application for Blarcamesine Anavex. The withdrawal follows the EMA’s recommendation to refuse authorisation due to lack of demonstrated effectiveness and safety concerns, including nitrosamine impurities. No marketing authorisation will be granted for Blarcamesine Anavex at this time. The EMA’s evaluation findings should be considered by companies involved in Alzheimer’s treatment development. Ongoing clinical trials and compassionate use programmes remain unaffected.
That wraps up today's regulatory updates. Visit carveragents.ai for more information.