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 covers the cross-cutting material: enforcement actions, general guidance, institutional and legislative change, and horizontal rules that touch pharmaceuticals, devices, digital health, and data at the same time.
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UK MHRA · UKForms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry
FDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.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 StatesCommission 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 consultation on statutory fees (2026)
Proposals for ongoing cost-recovery and to fund higher value services.
UK MHRA · UKFAQ on Swissmedic Fees Ordinance
Swissmedic publishes frequently asked questions explaining its practice on fee charging under the Fees Ordinance, effective 1 September 2026.
Swissmedic · SwitzerlandPublication 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
Greece EOF · GreeceGood laboratory practice (GLP) for safety tests on chemicals
Keep up to date with the latest information from the UK GLP monitoring authority.
UK MHRA · UKEuroHPC 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 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) · SpainCommission 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.
EUR-Lex Official Journal · 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-widePrescription 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 StatesRescission 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 StatesReducing 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 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) · NetherlandsModification 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 StatesEstablishment 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 StatesInformation 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 · LithuaniaAI Act complaints tool
The AI Act Complaint Tool allows individuals and organisations to submit complaints to the AI
EU AI Act Implementation · EU-wideANS-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) · SwedenCari-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 · 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
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-wideMHRA 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-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-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 StatesJAZMP telephone service disruption notice
Telephone access to JAZMP may experience intermittent disruptions over the next two days due to technical maintenance work.
Slovenia JAZMP · SloveniaAgenda: 40th meeting of the Expert Group on Health Systems Performance Assessment (1 October 2026)
News announcement 31 August 2026 Agenda - 40th meeting of the Expert Group on Health Systems Performance Assessment (1 October 2026) Agenda - 40th meeting of the Expert Group on Health Systems Performance Assessment (...
EC Public Health · EU-wideExecutive Vice-President Virkkunen in the US for G20 Ministerial meetings
Starting today until Wednesday, 2 September, the European Commission will be represented by Henna Virkkunen, Executive Vice-President for Tech Sovereignty, Security and Democracy and Valdis Dombrovskis, Commissioner f...
EU AI Act Implementation · EU-wideEMA new webpage on women's health
Discover how EMA is advancing women’s health in medicines development and regulation Developers can submit New Approach Methodologies data and receive tailored feedback Evidence based information addressing concerns, ...
EMA - European Medicines Agency · EU-wideRegulatory & Beyond 2026 event programme now online
This year's “Regulatory & Beyond” event takes place on 16 November 2026 at the Kursaal, Bern. This event brings together experts from industry, authorities and other regulatory fields. The full programme is now availa...
Swissmedic · SwitzerlandStudent internship at Lithuania's State Medicines Control Service provided insight into daily regulatory work
Šią vasarą Valstybinėje vaistų kontrolės tarnyboje (VVKT) praktiką atliko Inesa ir Žygimantas. Praktikos metu studentai turėjo galimybę ne tik susipažinti su kasdiene Tarnybos veikla, bet ir iš arčiau pa...
Lithuania VVKT · LithuaniaMeet our volunteers: an interview with Joe Walsh
Joe Walsh is a retired chartered engineer and has been a Research Ethics Committee (REC) member for almost a decade. Alongside his role as a member, Joe also volunteers for local charities. Here he shares his experien...
UK Health Research Authority · UKPharmacies invited to report temporary service interruptions
The State Agency of Medicines requests pharmacies to report temporary operational disruptions including power, internet or other service failures.
Latvia ZVA (State Agency of Medicines) · LatviaInfarmed publishes July 2026 performance indicators
O Infarmed disponibiliza indicadores relativos aomês de julho, destacando algumas atividades que contribuem para garantir aos cidadãos a qualidade, segurança e eficácia dos medicamentos e produtos de saúde, bem como a...
Portugal INFARMED · PortugalYou've got the grades, but don't pass on your health
Medicines and medical devices regulator issues health advice for teens off to university.
UK MHRA · UK
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