Guidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to drive healthcare advancements and accelerate patient access to innovation and new treatments.
UK MHRA · UKGeneral Regulatory
Regulation
Category
Type
Date
EDPB harmonises fining methodology and adopts final DSA-GDPR guidelines
EDPB adopts guidelines on administrative fines under GDPR and on interplay between Digital Service Act and GDPR.
EDPB (European Data Protection Board) · EU-wideMedical Device User Fee Rates for Fiscal Year 2027
FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesEU Products Liability Directive (EU) 2024/2853 – National Transposition
Directive clarifies 'product' definition to include digital manufacturing files and software, modernizing liability framework for AI-enabled devices and SaMD.
EUR-Lex Official Journal · EU-wideMHRA Strategy to 2030: guidance on implementation
A series of explainers to help you understand the parts of the MHRA Strategy to 2030 most relevant to you, and what they mean in practice.
UK MHRA · UKHealth Bill: MHRA reforms - impact assessments
Impact assessment framework for proposed Medicines and Healthcare products Regulatory Agency reforms under the Health Bill.
UK DHSC Policy Papers & Consultations · UKGuidance: MHRA Innovation Accelerator
The Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRA · UKCommission Implementing Decision (EU) 2026/901 on European standards for products under Regulation (EU) 2023/988, repealing Decision (EU) 2019/1698
Implementing decision establishing European standards for products under the medical devices framework, repealing the prior 2019 decision.
EUR-Lex Official Journal · EU-wideMHRA Innovation Office: guidance and support
We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
UK MHRA · UKForms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry
FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
US Federal Register - FDA Guidance Notices · United StatesEuroHPC Regulation amended to strengthen Europe's AI and quantum capabilities
The EuroHPC Regulation has been amended to enhance Europe's artificial intelligence and quantum computing infrastructure capabilities.
EC AI Act & Regulation · EU-wideDigital Europe Programme amended to accelerate the Commission's digital ambitions
The Digital Europe Programme has been amended to accelerate the Commission's digital ambitions.
EC AI Act & Regulation · EU-wideEU HTA Regulation Implementation: Factsheets and guidance materials
Factsheets on joint clinical assessment and scientific consultation procedures under the EU HTA Regulation, plus implementation guidance and analysis of regional cooperation structures.
EU HTA Regulation Implementation · EU-wideAEPD promotes common compliance model in public sector with recommendations and next actions
Spanish data protection agency publishes GDPR compliance recommendations for public administration, developed through dialogue with data protection officers.
AEPD (Spanish Data Protection Agency) · SpainLaunch of new information newsletter
Glada nyheter för den som vill få en samlad bild av vad som händer på E-hälsomyndigheten. Nu har det första numret av vårt nya informationsbrev skickats till prenumeranterna.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenCall for articles: Revista PIT third issue on GDPR interaction with AI, digital services, cybersecurity and health regulations
(15 de octubre de 2026).La relación entre el Reglamento General de Protección de Datos (RGPD) y el creciente número de normas que regulan aspectos como la inteligencia artificial, los servicios digitales, la cibersegu...
AEPD (Spanish Data Protection Agency) · SpainMHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out ambitious plans to translate cutting-edge scientific and technological innovation into better health outcomes for patients across all four nat...
UK MHRA · UKHow NICE prepares for the healthcare of tomorrow
In this episode, we explore the research taking place behind the scenes at NICE and how it helps us prepare for the future of healthcare. From new medicines and digital health technologies to artificial intelligence a...
UK NICE · UKAI chatbot provides quick answers about Medicinrådet
På medicinraadet.dk kan brugerne få hjælp af chatbotten MAIA til at finde svar på faktuelle spørgsmål om habilitet, Medicinrådets vurderinger af nye lægemidler, faglige begreber og meget mere. Chatbotten bruger kunsti...
Medicinrådet (Danish Medicines Council) · DenmarkFrench Digital Health Agency: roadmap 2026-2028
Communiqué de presse
ANS - French Digital Health Agency · FranceAI Act Complaints Tool
The AI Act Complaints Tool allows individuals and organisations to submit complaints to the AI
EU AI Act Implementation · EU-wideCNIL plenary session agenda, 15 October 2026
La Commission nationale de l'informatique et des libertés s’est réunie le jeudi 15 octobre 2026 à 9 h 30 avec l’ordre du jour suivant :
CNIL - Health Data · FranceCNIL plenary session agenda, 8 October 2026
La Commission nationale de l'informatique et des libertés s’est réunie le jeudi 8 octobre 2026 à 9 h 30 avec l’ordre du jour suivant :
CNIL - Health Data · FranceEuropean Biotech Clusters: Connect. Collaborate. Scale — Turning the Biotech Act's ambition into action
Registration - European Biotech Clusters: Connect. Collaborate. Scale: Turning the Biotech Act’s ambition into action (19 November 2026)
EC Public Health · EU-wideFunding opportunity launched to strengthen UK regulatory science and support healthcare innovation
Four new centres of excellence will bring together expertise across academia, industry, healthcare and regulation to keep pace with advances in healthcare and life sciences
UK MHRA · UKInfarmed launches INOV@INFARMED innovation network and strengthens partnership between science and regulation
Infarmed established a structured collaboration network with academic institutions to advance research in medicines, medical devices, and health technology assessment.
Portugal INFARMED · PortugalInformation on disruptions to connections with EU regulatory information systems
Technical disruptions affecting connections to EU regulatory information systems (CTS, EURS, Eudamed and others) reported from 27 August 2026.
Lithuania VVKT · LithuaniaBioVigilance web application launched for reporting adverse events related to substances of human origin
FAMHP launches BioVigilance, an online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin intended for human application.
FAMHP (Belgian Medicine Agency) · BelgiumAEPD reopens registration for public network of research groups and projects on privacy and emerging technologies
Spanish Data Protection Agency reopens registration for its public research network on privacy and emerging technologies, welcoming research groups and individual researchers.
AEPD (Spanish Data Protection Agency) · SpainAI Act Whistleblower Tool
The AI Act Whistleblower Tool empowers individuals to securely submit a report and contribute
EC AI Act & Regulation · EU-wideCari-Anne Quinn: Turning possibility into progress – health innovation in Wales
Wales’ connected health and life sciences ecosystem creates opportunities to support innovation from development through to adoption, helping new products reach patients while supporting investment and growth.
UK MHRA · UKProfessor Joann Rhodes: The Rules Need to Bend – Why Flexible Policies and Real Partnership are the Keys to unlocking Life Sciences Potential
Innovation doesn’t wait for the rules to catch up. The question is whether we can build a system agile and flexible enough to keep pace.
UK MHRA · UKMedicines and Medical Devices Act 2021: 5 year report
Report assessing how UK human and veterinary medicines and medical devices legislation has operated from 2021 to 2026.
UK DHSC · UKHealth Technology Assessment – 2026 Work Programme adopted
News announcement 2 December 2025 Health Technology Assessment – 2026 Work Programme adopted Health Technology Assessment – 2026 Work Programme adopted 1 min read
EC Public Health · EU-wideHAS Autumn University – 20 November 2026
Free online event featuring recent recommendations, expert exchanges, and sessions on AI deployment in healthcare contexts.
Haute Autorité de Santé (HAS) · FranceEMA and EISMEA boost cooperation to accelerate health innovations
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today, EMA’s Executive Director Emer Cooke and...
EMA - European Medicines Agency · EU-wideEDPB calls for legal basis for cross-regulatory information sharing
EDPB calls for a clear legal basis enabling information sharing among regulators with different competences to support consistent GDPR application.
EDPB (European Data Protection Board) · EU-wideEU HTA Regulation: implementation rolling plan
TheRegulation (EU) 2021/2282 on health technology assessment(HTAR) entered into force on 11 January 2022 and applies from 12 January 2025.
EU HTA Regulation Implementation · EU-wide
Showing 47 of 47 tracked updates
— health-tech relevant only. Show all health policy