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.
US Federal Register - FDA Notices · United States
Category
General Regulatory
Not every regulatory development fits a single product category. This page collects cross-cutting health regulation and policy that HealthSignal tracks, including enforcement actions, general guidance, institutional and legislative changes, and horizontal rules that touch pharmaceuticals, devices, digital health, and data at the same time. Every item is drawn from official public bodies across the EU, the UK, Switzerland, and the US, at the level of regulation, policy, and law.
Regulation
Category
Type · Breadth
Date
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.
UK MHRA · UKEU 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 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UK MHRA · UKForms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry
FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.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 StatesGood laboratory practice (GLP) for safety tests on chemicals
Keep up to date with the latest information from the UK GLP monitoring authority.
UK MHRA · UKPrescription Drug User Fee Rates for Fiscal Year 2027
FDA announces prescription drug user fee rates for FY 2027 under PDUFA VII.
US Federal Register - FDA 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-wideAEPD promotes a common compliance model in the public sector with recommendations and next actions
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AEPD (Spanish Data Protection Agency) · SpainReducing 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...
US Federal Register - HHS Rules · United StatesReducing 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...
US Federal Register - HHS Rules · United StatesRescinding 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.
US Federal Register - HHS Rules · United StatesDesignated 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...
US Federal Register - HHS Rules · United StatesModification 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.
US Federal Register - FDA Rules · United StatesEU 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-wideRescission 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.
US Federal Register - HHS Rules · United StatesAmendment 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...
US Federal Register - FDA Rules · United StatesMEB 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.
CBG-MEB (Dutch Medicine Agency) · NetherlandsAI Act complaints tool
The AI Act Complaint Tool allows individuals and organisations to submit complaints to the AI
EU AI Act Implementation · EU-wideEstablishment Registration and Product Listing for Tobacco Products
FDA proposes to extend establishment registration and tobacco product listing requirements to foreign owners and operators, currently exempt.
US Federal Register - FDA Rules · United StatesMHRA consultation on statutory fees - proposals on ongoing cost recovery
Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs.
UK MHRA · UKTargeted consultation on EU4Health: have your say on future priorities, orientations and needs
European Commission invites input on future priorities, orientations and needs for the EU4Health programme.
EC Public Health · EU-wideLife Sciences Healthcare Goals
UK DHSC launches Healthcare Goals programme bringing together industry, academia, third sector and NHS to advance prevention, diagnosis, treatment and monitoring in dementia, cancer, mental health, obesity and addiction.
UK DHSC · UKBioVigilance 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
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AEPD (Spanish Data Protection Agency) · SpainLorenzo Cotino: "AI governance requires the involvement of all institutions and a special commitment from companies"
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AEPD (Spanish Data Protection Agency) · SpainANS-Formation: new interactive content on e-health uses added to platform
ANS-Formation platform launches new immersive module 'The e-health city' offering interactive discovery of digital health applications and use cases.
ANS - French Digital Health Agency · FranceSwedish National Board of Forensic Medicine: Regulations on Special Risk Assessment (HSLF-FS 2026:5)
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Socialstyrelsen - Föreskrifter (SE) · SwedenEDPB 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-wideProfessor 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 · UKSwissmedic Journal
The Swissmedic Journal is the official periodical of the Swiss Agency for Therapeutic Products and appears monthly, in German and French. It is published in the middle of the following month on this website. The Swiss...
Swissmedic · SwitzerlandEuropean Health Data Space: Eurobarometers
European Health Data Space · EU-wideEuropean Health Data Space: Consultations
European Health Data Space · EU-wideDigital Inclusion Action Plan: One Year On
Progress report on delivering the Digital Inclusion Action Plan.
UK DHSC · UKBfArM: News from the divisions
New information and updates on our website. New information in the topic medicinal products New information in the topic licensing New information in the topic clinical trials New information in the topic Pharmacovigi...
BfArM (Federal Institute for Drugs) · GermanyEU launches AI Gigafactories call to boost Europe's computing capacity and unlock more than €30 billion in investment
The EU has launched a call for tenders to establish up to seven AI Gigafactories across Europe, as part of its latest major push to accelerate Europe's technological sovereignty and ambition of becoming the AI Contine...
EU AI Act Implementation · EU-wideMedicine Register: check medicine availability in pharmacies
Latvia's State Agency of Medicines enhanced the Medicine Register to display pharmacy availability with a green checkmark indicator.
Latvia ZVA (State Agency of Medicines) · LatviaAEPD Privacy Lab invites submission of projects, research and initiatives
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AEPD (Spanish Data Protection Agency) · SpainNotice on additions to the EDQM Standard Terms database
Polish translations of new standard terms for routes of administration and organ preservation have been added to the EDQM Standard Terms electronic database.
Poland URPL · PolandNotice of Ministry of Health Supervision over the Work of the Public Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP)
Zainteresirano javnost obveščamo, da je Ministrstvo za zdravje (v nadaljevanju: MZ) na podlagi četrtega odstavka 180. člena Zakona o zdravilih (Uradni list RS, št. 17/14, 66/19, 102/24 – ZZKZ, 24/25, […]
Slovenia JAZMP · SloveniaNICE annual report and accounts 2025 to 2026
Our annual report and accounts covering April 2025 to March 2026 highlight our key achievements. Find out how we’re delivering against the 10 Year Health plan, and how we’re becoming more relevant, timely, impactful a...
UK NICE · UKAI Act Whistleblower Tool
The AI Act Whistleblower Tool empowers individuals to securely submit a report and contribute
EC AI Act & Regulation · EU-wideDEA Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants
DEA proposes adjusting fee schedule for controlled substance and List I chemical registrants to recover Diversion Control Program costs.
US Federal Register - DEA Telehealth Rules · United StatesTwin project partners in Berlin assessed project progress: people and long-term partnership are key
Informacija pateikiama šiomis kalbomis: 🇱🇹 🇪🇺 🇺🇦 / Information is available in the following languages: 🇱🇹 🇪🇺 🇺🇦 / Інформація доступна такими мовами: 🇱🇹 🇪🇺 &n...
Lithuania VVKT · LithuaniaItalian Data Protection Authority presents annual report to Parliament on 2 July
Il Garante privacy presenta la Relazione annuale Il 2 luglio alla Camera dei Deputati. Il bilancio dell’attività 2025 e le sfide future L’Autorità Garante per la protezione dei dati personali pre[...]
Garante Privacy (Italian DPA) · ItalyItalian Data Protection Authority: 2025 Activity Report – Press Summary
- Scarica la RelazIone annuale RELAZIONE SULL’ATTIVITÀ 2025Sintesi per la stampa L’AutoritàGarante per la protezione dei dati personali- composta daPasquale Stanzione,Ginevra Cerrina Feroni,Agostino Ghiglia- presenta ...
Garante Privacy (Italian DPA) · Italy132nd Meeting of the EMA Management Board
W dniach 10–11 czerwca 2026 r. odbyło się 132. posiedzenie Rady Zarządzającej Europejskiej Agencji Leków (EMA) w Amsterdamie. Polskę reprezentował Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i ...
Poland URPL · Poland
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