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Global regulatory updates

Follow FDA, EMA, PMDA, MHRA, and other agencies across approvals, warnings, inspections, guidance, and drug policy signals.

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🇺🇸Regulatoryfederalregister.gov

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Center for Scientific Review; Notice of Closed Meetings

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information

The Office of the Assistant Secretary for Health (OASH or we) is opening a public docket to solicit...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Patient Safety Organizations: Voluntary Relinquishment for the Cassatt Patient Safety Organization

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on beha...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Calendar 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) Po

This proposed rule would set forth routine updates to the Medicare home health payment rates in acco...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Expedited Investigational New Drug Pilot Program; Request for Information; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Proposed Collection; 60-day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director)

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Privacy Act of 1974; Matching Program

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Heal...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce pub...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Agency Forms Undergoing Paperwork Reduction Act Review

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE...

Federal RegisterOriginal source
🌍Regulatorywho.int

Ebola disease caused by Bundibugyo virus, Democratic Republic of the Congo & Uganda

WHO Disease Outbreak NewsOriginal source
🇬🇧Regulatoryabpi.org.uk

Disclosure UK 2025: the 11th year of Disclosure UK data, with industry transparency continuing to grow

ABPI UKOriginal source
🇬🇧Regulatorygov.uk

Air Pollution Awareness Coalition (APAC)

The Air Pollution Awareness Coalition (APAC) is a cross-sector coalition to improve public understan...

UK Department of Health and Social CareOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.ca

Urinary Catheter Trays containing Cliniclean Pericare Wipes

Based on customer feedback, BD has identified that the Cliniclean Pericare Wipes provided within uri...

Health Canada Recalls and Safety AlertsOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.ca

Omni-Tract Surgical Retractor System

Integra Lifesciences is issuing a correction to the Integra® Omni-Tract® Surgical Retractor System -...

Health Canada Recalls and Safety AlertsOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.ca

Intramedullary Bone Saw Blade Assembly

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary...

Health Canada Recalls and Safety AlertsOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.ca

Hybrid Hydrophilic Microguidewire

Performance variability affecting the hydrophilic coating of Hybrid007 guidewires in specific lots m...

Health Canada Recalls and Safety AlertsOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.ca

DLP Select 3D Arterial Cannula and DLP Elongated One Piece Arterial Cannulae

Beginning in April 2026, complaints were received regarding pinhole leaks in the wire-wound body of...

Health Canada Recalls and Safety AlertsOriginal source
🇬🇧Regulatorygov.uk

Ebola and Marburg: returning workers scheme (RWS)

Advice for people returning to the UK after working in an Ebola or Marburg virus affected area.

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Ebola and Marburg haemorrhagic fevers: outbreaks and case locations

Information about incidents and outbreaks of Ebola and Marburg, both viral haemorrhagic fevers (VHF)...

UK Health Security AgencyOriginal source
🇬🇧Regulatoryabpi.org.uk

UK clinical trials performance improves but remains in intensive care

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Regulatory renewal needed for UK life sciences ambitions

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI welcomes the Innovation Ecosystem Programme Review

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI welcomes the appointment of new MHRA Chair

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

The King’s Fund calls on NHS leaders to help unlock power of industry partnerships

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

UK missing opportunity to unlock medicines for severe conditions

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI response to Sudlow review on the use of health data

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI welcomes the Chancellor’s backing of life sciences in the Budget

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Fixing NHS needs greater investment in medicines, says ABPI

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

MPs and peers urge Chancellor to support the life sciences in Budget

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Partnerships build trust between industry and healthcare professionals

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Labour budget can unlock UK life science opportunities

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Emerging research points to NHS and industry being a successful partnership for patients

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI response to United Nations General Assembly political declaration on antimicrobial resistance

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Government must free NICE to unlock access to medicines for severe conditions

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI welcomes Chancellor’s speech at Labour party conference

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

2024 ABPI Code of Practice launched, with a new constitution and procedure for the PMCPA

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

PM says life sciences is a key partner to fixing the NHS

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI response to the Darzi Review: innovation must be at the heart of improvement

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Industry calls on government to boost investment in commercial clinical trial capacity to drive £3 billion extra economic growth, 26,000 new jobs

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Russell Abberley, Amgen UK & Ireland, steps up as Acting ABPI President

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

UK secures £400 million investment to boost clinical trials

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

UK must get ready for new cell and gene therapies, says ABPI

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI response to the government's commitment to boost research by improving access to NHS data

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI respond to the government's Skills England announcement

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI welcomes RSV national vaccination programme

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

New research shows why Gen-Z is choosing to work in pharma

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

New data shows UK life sciences failing to reach its potential

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

ABPI respond to Wes Streeting’s commitment to boosting the economy through the life sciences sector

ABPI UKOriginal source
🇬🇧Regulatoryabpi.org.uk

Life sciences sector a vital partner for Labour’s plans

ABPI UKOriginal source
🇬🇧Regulatorygov.uk

Weekly all-cause mortality surveillance: week ending 12 July 2026

How the actual number of deaths in England compare with expected numbers for each week.

UK Health Security AgencyOriginal source
🌍Regulatoryeof.gr

Γενόσημα Απριλίου 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση

EOF GreeceOriginal source
🇬🇧Regulatorygov.uk

Weekly all-cause mortality surveillance: week ending 5 July 2026

How the actual number of deaths in England compare with expected numbers for each week.

UK Health Security AgencyOriginal source
🌍Regulatoryeof.gr

ERKEXIN / (ΣΙΛΔΕΝΑΦΙΛΗ, ΤΑΛΑΔΑΦΙΛΗ)

EOF GreeceOriginal source
🌍Regulatoryeof.gr

Ανάκληση των παρτίδων του παρακάτω πίνακα, του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIa, Αρτηριακές κάνουλες ΕΟΡΑ

EOF GreeceOriginal source
🌍Regulatoryeof.gr

Ανάκληση των σειριακών αριθμών 109980699 και 110143347 του κωδικού 1739994, του Ιατροτεχνολογικού προϊόντος MDD Class I, Adapter for Head positioning (εξάρτημα προσαρμογής για τοποθέτηση κεφαλής).

EOF GreeceOriginal source
🇬🇧Regulatorygov.uk

Guidance: Best practice in the labelling and packaging of medicines

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Guidance: Submit changes to labels and Patient Information Leaflets as a self-certification

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Measles, mumps or rubella (MMR) referral form

MMR diagnostic form (E8): PCR, genotyping and serology tests

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Our governance

Details of framework agreement, leadership structure and advisory board information.

UK Health Security AgencyOriginal source
🇩🇰Regulatorylaegemiddelstyrelsen.dk

Register-based study suggests a slightly increased risk of meningiomas in women using hormonal contraception containing a progestogen

Danish Medicines AgencyOriginal source
🇺🇸Regulatoryopen.fda.gov

Drug label update: Essentials Whiten and Strengthen

Official structured record identifier: 96548550-2cd1-b757-e053-2995a90a15ea.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.gov

Drug label update: Sensitive Teeth and Gums

Official structured record identifier: 935172db-d78f-0c69-e053-2a95a90a0b69.

openFDA Drug LabelsOriginal source
🇬🇧Regulatorygov.uk

Keep Britain Working review update: March 2026

An update on the implementation of the independent review of the role of employers in tackling healt...

UK Department of Health and Social CareOriginal source
🇬🇧Regulatorygov.uk

Keep Britain Working review update: June 2026

June 2026 update on implementing the independent review of employers' role in tackling health based...

UK Department of Health and Social CareOriginal source
🇬🇧Regulatorygov.uk

Keep Britain Working

We are now implementing the recommendations of the Keep Britain Working independent review of the ro...

UK Department of Health and Social CareOriginal source
🌍Regulatorycssp.gob.sv

Procesos de Compras UCP

Consejo Superior de Salud Pública (El Salvador)Original source
🇬🇧Regulatorygov.uk

NHS patients get faster access to medicines under new pilots

NHS patients could access cutting-edge medicines potentially months earlier under a series of pionee...

UK Department of Health and Social CareOriginal source
🇺🇸Regulatoryfda.gov

Drug Alerts and Statements

FDA Drug Safety CommunicationsOriginal source
🌍Regulatorywho.int

Hantavirus outbreak linked to cruise ship travel, Multi-locations

WHO Disease Outbreak NewsOriginal source
🇬🇧Regulatorygov.uk

NHS injury costs recovery scheme: April 2026 to March 2027

Data on the funds collected by the Compensation Recovery Unit and funds paid to the NHS.

UK Department of Health and Social CareOriginal source
🇬🇧Regulatorygov.uk

Medicines: apply for a variation to your marketing authorisation

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Work-related quality of life of the adult social care workforce in England in 2025

Survey results from the second wave of the Adult Social Care Workforce Survey, undertaken between Au...

UK Department of Health and Social CareOriginal source
🇬🇧Regulatorygov.uk

Guidance: Medicines that you cannot export from the UK or hoard

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Outbreaks under monitoring in 2026

Latest information on global disease events under monitoring.

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Weekly all-cause mortality surveillance: 2025 to 2026

How the actual number of deaths in England compare with the expected numbers of deaths for each week...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

National flu and COVID-19 surveillance reports: 2025 to 2026 season

National influenza (flu) and COVID-19 report, monitoring COVID-19 activity, seasonal flu and other s...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Syndromic surveillance: weekly summaries for 2026

This weekly summary highlights changes in the number of people visiting GPs, going to emergency depa...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Remote health advice: weekly bulletins for 2026

Summary of the number of people calling NHS 111 for health advice within England on a weekly basis u...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

National ambulance syndromic surveillance: weekly bulletins 2026

The number of people calling ambulances each day, with results published every week under the syndro...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

GP out-of-hours syndromic surveillance: weekly bulletins for 2026

The number of people contacting their GPs outside of surgery hours under the syndromic surveillance...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

GP in-hours: weekly bulletins for 2026

Monitors the number of people who visit their GP during surgery hours under the syndromic surveillan...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Emergency department: weekly bulletins for 2026

The number of people going to emergency departments each day, with results published every week unde...

UK Health Security AgencyOriginal source