The Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. The Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital health ecosystem as part of the European data strategy. The EHDS will provide a comprehensive framework for the access to and use …
The Critical Medicines Alliance, a consultative mechanism bringing together relevant stakeholders from EU Member States, key industries, the civil society, and the scientific community, have published a report with key findings and proposed recommendations covering various different challenges of the supply chains of critical medicines. On the main industrial challenges, the Report notes an overreliance on a limited …
The main purpose of the new list is to improve the quality of the risk assessment of hazardous medicinal products (HMPs). It aims at further strengthening the safety of workers due to the exposure to HMPs. The Commission issued on 18 February 2025 a Communication establishing an Indicative list of hazardous medicinal products. It completes the previous Guidance for the …
The Commission published a report aimed at supporting Member States in addressing low-value care as part of their work on reforming health systems. The report will be presented on 13 February from 14.00 to 15.00 CET Brussels time at a #EUHPP Live Webinar “Identifying, measuring and reducing low-value care in the context of health system performance assessment”. After a presentation …
The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on …
The Commission has launched a new Biotech and Biomanufacturing Hub to support companies – particularly start-ups and SMEs – in bringing innovative products to the EU market and increase their competitiveness. The Hub will also help companies identify the support available to them at EU level and how to access this support to help them to expand and grow. …
The European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering: the submission of requests from health technology …
The Commission has presented an EU action plan aimed at bolstering the cybersecurity of hospitals and healthcare providers. This Action Plan was announced in President von der Leyen‘s political guidelines as a key priority within the first 100 days of the new mandate. The initiative is an important step in shielding the healthcare sector from cyber threats. …
The Regulation on Health Technology Assessment (HTA) has become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This …
National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials …