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.
Implementation of the Clinical Trials Regulation
ACT EU - Accelerating Clinical TrialsFood Standards of Identity Modernization; Pasteurized Orange Juice
The Food and Drug Administration (FDA or we) is issuing a final rule to amend the standard of identity for pasteurized orange juice by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg]...
US Federal Register - FDA RulesWest Nil Virus (WNV) – FrankreichNeu
West Nil Virus (WNV) – Frankreich Neu Sicherheitsinformation | Blut & Gewebe | 17.07.2026 Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der französischen Behörde mitgete...
Austria BASGFlash report published: Member State Coordination Group meeting on 16 July 2026
News announcement 16 July 2026 Flash report published: Member State Coordination Group meeting on 16 July 2026 Flash report published: Member State Coordination Group meeting on 16 July 2026 1 min read
EC Public HealthDRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - PE789.094v01-00
DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and...
European Parliament - SANT Subcommittee (Public Health)Thousands eligible for new chronic heart failure treatment following NICE recommendation
People in England with a type of chronic heart failure could benefit from a new treatment option. Our final draft guidance recommends finerenone for adults with chronic heart failure with preserved or mildly reduced e...
UK NICEMedicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
This proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative ...
US Federal Register - CMS RulesRequest for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks inpu...
US Federal Register - CMS RulesUpdated warnings for botulinum toxin products following rare cases of botulism
The MHRA is strengthening safety warnings for all botulinum toxin type A products, following reports of rare cases of botulism linked to their use.
UK MHRAUK-donor plasma given go-ahead for new medicines
Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority plasma-derived medicinal products.
UK MHRAClinical trials for medicines: Clinical Trials Regulations transitional arrangements
Guidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRABotulinum toxin type A products: updated warnings regarding risk of iatrogenic botulism
Cases of iatrogenic botulism have been reported following the therapeutic or cosmetic use of botulinum toxin containing products where the toxin’s effect extends beyond the area of treatment. Patients should seek imme...
UK MHRAGuidance: International Recognition Procedure
How to use the procedure for medicines licensing applications.
UK MHRAHighlights - Medical Devices Regulation - consideration of draft report - Committee on Public Health
<div style="float: left; margin: 0px 5px 0px 0px;"><img alt="Medical ventilator being monitored by anaesthetist" src="https://www.europarl.europa.eu/resources/library/images/20230508PHT85501/20230508PHT85501-ms.jpg" t...
European Parliament - SANT Subcommittee (Public Health)DRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare - PE790.010v03-00
DRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare<br />Committee on Public Health<br />Giorgos Georgiou<br /> <br />Source : <a href="https://www.e...
European Parliament - SANT Subcommittee (Public Health)Field Safety Notices: 6 to 10 July 2026
List of Field Safety Notices from 6 to 10 July 2026.
UK MHRAGuidance: In vitro diagnostic point-of-care test devices
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
UK MHRAClass 2 Medicines Recall: Beckton Dickson UK Ltd, ChloraPrep 1mL applicator, EL(26)A/34
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
UK MHRAUpdated list of notified bodies’ standard fees
News announcement 13 July 2026 Updated list of notified bodies’ standard fees Updated list of notified bodies’ standard fees 1 min read
EC Public HealthDrug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and...
US Federal Register - FDA RulesQuestions and answers (version 22) - Safety features for medicinal products for human use
News announcement 10 July 2026 Questions and answers (version 22) - Safety features for medicinal products for human use 1 min read
EC Public HealthSummary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026)
News announcement 8 July 2026 Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026) 1 min read
European Health Data SpaceNovel life-saving liver procedure recommended, potentially enabling hundreds more transplants
A procedure that keeps donor livers supplied with oxygen inside the body before removal has been recommended for NHS use and could help more people on the transplant waiting list.
UK NICENew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), ...
US Federal Register - FDA RulesMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots
This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experi...
US Federal Register - CMS RulesRecission of the National Cancer Institute Clinical Cancer Education Program Regulation
The Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (N...
US Federal Register - HHS RulesCommission presents EU Action Plan on Cybersecurity and Artificial Intelligence
PRESS RELEASE | 07 July 2026 Commission presents EU Action Plan on Cybersecurity and Artificial Intelligence
EU AI Act ImplementationWhy do we need rules on AI?
The AI Act is the first-ever legal framework on AI, which addresses the risks of AI and positions Europe to play a leading role globally.
EU AI Act ImplementationCalendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies
This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior ad...
US Federal Register - CMS RulesGuidance: Submit changes to labels and Patient Information Leaflets as a self-certification
Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.
UK MHRAMaking regulation a catalyst, not a barrier, for UK life sciences
MHRA CEO argues that for the UK’s long-term health and prosperity, regulation should help lead, rather than follow, innovation
UK MHRAResearch: MHRA data requirements to support regulatory decision making
A regulator’s view on what the new UK Health Data Research Service must deliver.
UK MHRAHSLF-FS 2026:27 Socialstyrelsens föreskrifter om ändring i Socialstyrelsens föreskrifter HSLF-FS (2023:33) om uppgiftsskyldighet till Socialstyrelsens patientregister
Artikelnummer: 2026-6-10367 | Publicerad: 2026-07-02 Visa mer
Socialstyrelsen - Föreskrifter (SE)Guidance: Best practice guidance on patient information leaflets
This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
UK MHRAJune 2026 updated information on the applications for designation as a notified body - Overview of CABs/NBs at each stage of the designation process
News announcement 1 July 2026 June 2026 updated information on the applications for designation as a notified body - Overview of CABs/NBs at each stage of the designation process June 2026 updated information on the a...
EC Public HealthNew draft PMOS guideline recommends annual review and could mean quicker diagnosis
People with polyendocrine metabolic ovarian syndrome (PMOS) should have their condition diagnosed sooner and be offered an annual review to monitor symptoms, treatment and long-term health risks, according to our draf...
UK NICEField Safety Notices: 22 to 26 June 2026
List of Field Safety Notices from 22 to 26 June 2026.
UK MHRAMedical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in thi...
US Federal Register - FDA RulesMedical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
The Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis into class II (special controls). The special controls that apply to the device type are identified in this order and...
US Federal Register - FDA RulesGuidance: Borderline products: medical devices and other products
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
UK MHRAGuidance: Innovation Accelerator
Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRAGuidance: 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 MHRAClass 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
UK MHRA