General Regulatory

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.

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.

Medical 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.

EU 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.

MHRA 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.

Health Bill: MHRA reforms - impact assessments

Impact assessment framework for proposed Medicines and Healthcare products Regulatory Agency reforms under the Health Bill.

Guidance: 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.

Commission 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.

Commission consultation on technology and copyright protection

The European Commission is gathering feedback on challenges and options for potential future measures to support the impact of technology, including artificial intelligence, on the effective copyright protection amid ...

MHRA Innovation Office: guidance and support

We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.

Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry

FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.

EuroHPC 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.

Removal of Obsolete/Suspended Regulations

IHS removes duplicate and never-implemented regulations from the CFR; no change to existing practices or authorities.

Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federa...

Commission Implementing Decision (EU) 2026/1819 amending instruments on authorisation holders and representatives for genetically modified organisms on the market

Amends multiple instruments to establish requirements for authorisation holders and their Union representatives for placing genetically modified organism products on the market.

Digital Europe Programme amended to accelerate the Commission's digital ambitions

The Digital Europe Programme has been amended to accelerate the Commission's digital ambitions.

EU 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.

Delivery guide for alcoholic beverages published; retail, serving and marketing guides updated

Finnish Supervisory Agency published new delivery guide for alcoholic beverages and updated guides on retail, serving and marketing following parliamentary amendments to remote selling, delivery and marketing rules.

Further Reducing Bureaucracy and Burden From the Administration for Native Americans

The Department of Health and Human Services, Administration for Children and Families proposes to further amend the Native American Programs Act regulations to streamline the part.

Reforming Federal Reporting and Assessments in Child Welfare

ACF proposes to remove regulations that implement title IV-B of the Social Security Act (the Act) because they are outdated and refer to dates that have passed, have been superseded by subsequent amendments to the Act...

Health Bill: patient safety measures - impact assessments

Impact assessment framework for proposed patient safety measure changes within the Health Bill, outlining objectives, rationale, costs and benefits.

MHRA consultation on statutory fees (2026)

Proposals for ongoing cost-recovery and to fund higher value services.

Publication of Frequently Asked Questions and Answers Guide for Scientific Events

Αναρτάται από το Γραφείο Προέδρου ΔΣ/ΕΟΦ, στο πλαίσιο των αρμοδιοτήτων του, Οδηγός Συχνών Ερωτήσεων και Απαντήσεων (Q&A) στην ελληνική και

Good laboratory practice (GLP) for safety tests on chemicals

Keep up to date with the latest information from the UK GLP monitoring authority.

Prescription Drug User Fee Rates for Fiscal Year 2027

FDA announces prescription drug user fee rates for FY 2027 under PDUFA VII.

Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals

HHS proposes to remove and renumber regulations on care and treatment of mentally ill US nationals returned from foreign countries.

AEPD 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.

Reducing Bureaucracy and Burden in Family Violence and Prevention Services

This final rule removes duplicative and unnecessary sections from the Family Violence Prevention and Services Program regulations. These amendments will streamline the Family Violence Prevention and Services regulatio...

Reducing Bureaucracy and Burden for Family Assistance Programs

This final rule amends the Grants to States for Public Assistance Programs regulations, the General Administration--State Plans and Grant Appeals regulations, the General Administration--Public Assistance Programs reg...

Rescinding Portions of the U.S. Department of Health and Human Services Title VI Regulations To Align With the Statutory Text and Conform to Executive Order 14281

HHS amends Title VI civil rights regulations to remove disparate-impact liability provisions and align with statutory text.

Modification of Certain Terminology in Title 21; Reopening of the Comment Period

FDA reopens comment period on proposed rule to replace 'gender' with 'sex' throughout Title 21 CFR to comply with Executive Order 14168.

Launch 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.

Call 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...

MHRA 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...

How 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...

Swissmedic Portal Release – New Features Available from 23 September 2026

Swissmedic Portal Release Notes – 23.09.2026

AI 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...

Rescission of the National Cancer Institute Clinical Cancer Education Program Regulation

HHS proposes to rescind the NCI Clinical Cancer Education Program grants regulation as obsolete and no longer necessary.

French Digital Health Agency: roadmap 2026-2028

Communiqué de presse

Europe's digital health infrastructure is being built collectively

Actualité

AI Act Complaints Tool

The AI Act Complaints Tool allows individuals and organisations to submit complaints to the AI

MEB planning tool for application submission time slots mandatory from 1 July 2025

Use of the MEB planning tool to reserve submission time slots becomes mandatory for all applicants from 1 July 2025.

Swedish National Board of Forensic Medicine: Regulations on Special Risk Assessment (HSLF-FS 2026:5)

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CNIL 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 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 :

European 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)

Funding 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

Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission

This rule finalizes the removal of the requirements issued in the Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children final rule that was published on April 30, 2024 (hereafter referred t...

Amendment and Revocation of Organizational Information Regulations

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available on the Agency's website. FDA is also revoking certain regu...