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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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🇬🇧Regulatorygov.uk

Decision: Parallel import licences granted in 2026

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Notifiable diseases: causative agents reports for 2026

Weekly data from UK laboratories on the number of cases of notifiable bacteria and viruses (see impo...

UK Health Security AgencyOriginal source
🌍Regulatoryeof.gr

Συμπερίληψη Ελλάδας στον κατάλογο χωρών αναφοράς του Αιγυπτιακού Οργανισμού Φαρμάκων.

EOF GreeceOriginal source
🇪🇸Regulatoryaemps.gob.es

Boletín sobre Seguridad de Medicamentos de Uso Humano. Junio de 2026

AEMPS (Spain)Original source
🇬🇧Regulatorygov.uk

Pneumococcal polysaccharide conjugate vaccine (PCV20) PGD template

Patient group direction (PGD) template to support the provision of pneumococcal polysaccharide conju...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

PCV (13-valent or 15-valent, adsorbed): patient group direction (PGD) template

PGD template to support the national pneumococcal polysaccharide conjugate vaccine (13-valent or 15-...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

DHSC privacy notice

Find out about DHSC's data protection policy and procedures.

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

Department of Health and Social Care record of processing activity (RoPA)

The record of processing activity lists the personal data being held and processed by the Department...

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

BCG Vaccine AJV: patient group direction (PGD) template

PGD template to support the administration of BCG Vaccine AJV to individuals under 16 years of age a...

UK Health Security AgencyOriginal source
🇪🇸Regulatoryaemps.gob.es

La AEMPS colabora con la agencia reguladora de Ghana para fortalecer sus capacidades para la evaluación de medicamentos biológicos

AEMPS (Spain)Original source
🇯🇵Regulatorypmda.go.jp

[SHINSA]Information on biosimilars is updated

PMDA JapanOriginal source
🌍Regulatorypharmac.govt.nz

Pharmac to refresh patient advisory function

Pharmac New ZealandOriginal source
🇺🇸Regulatorysec.gov

AstraZeneca filed Form 6-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

BioNTech filed Form 6-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

GSK filed Form 6-K

SEC EDGAROriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Allergy and Infectious Diseases; Notice of Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Allergy and Infectious Diseases; Notice of Meetings

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements

This final rule updates the hospice wage index, payment rates, and aggregate cap amount for fiscal y...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Mental Health; Notice of Closed Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Reducing Bureaucracy and Burden in Family Violence and Prevention Services

This final rule removes duplicative and unnecessary sections from the Family Violence Prevention and...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Center for Advancing Translational Sciences; Notice of Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

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

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the propose...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs)...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrument...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Ricardo Andres Acuna: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Dru...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Angela Anatilde Baquero: Final Debarment Order

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Dru...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Notice Regarding 340B Rebate Model Pilot Program

The U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guid...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Nursing Research; Notice of Partially Closed Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Partially Closed Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Institute of Environmental Health Sciences; Notice of Partially Closed Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical

The Drug Enforcement Administration is proposing to modify the listing of the list I chemical 3,4-MD...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft g...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0906-0087-Revision

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Req...

Federal RegisterOriginal source
🇬🇧Regulatorygov.uk

UKHSA updates heat health alerts across England

An amber heat-health alert has been issued for the East Midlands, East of England, South East and Lo...

UK Health Security AgencyOriginal source
🌍Regulatorynafdac.gov.ng

NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the global community in celebrating World Breastfeeding Week 2026

NAFDAC NigeriaOriginal source
🌍Regulatorywho.int

Ebola disease caused by Bundibugyo virus - Democratic Republic of the Congo

WHO Disease Outbreak NewsOriginal source
🌍Regulatorycssp.gob.sv

Lanzamiento de la app DoctorSV para atención médica virtual

Consejo Superior de Salud Pública (El Salvador)Original source
🌍Regulatorycssp.gob.sv

Acto de juramentación de nuevos miembros del Consejo Directivo y Junta de Vigilancias

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

Immunoglobulin: when to use

UK Health Security Agency's immunoglobulin handbook, providing guidance on administering immunoglobu...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

UK Clinical Research Delivery key performance indicators: data to August 2026

Report bringing together data on the delivery of globally competitive clinical research through the...

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

Malaria prevention guidelines for travellers from the UK 2026

The UK Malaria Expert Advisory Group (formerly the Advisory Committee on Malaria Prevention) updates...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Government takes action to crack down on rogue funeral operators

Urgent work to take place to protect bereaved families.

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

Childhood vaccination coverage: provisional monthly data for England

Monthly data and commentary on coverage achieved by the UK childhood vaccination programme in Englan...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

2024 VPAG operational review minutes

Minutes of meetings held between the government, NHS England and ABPI about the 2024 voluntary schem...

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

2024 VPAG operational review: 12 August 2025

Minutes of a meeting held between the government, NHS England and ABPI about the 2024 voluntary sche...

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

Decision: Medical devices given exceptional use authorisations

MHRA UKOriginal source
🌍Regulatoryeof.gr

Απαγόρευση κυκλοφορίας του προϊόντος TEMPUFEN της εταιρείας ANTALIA PHARMA ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε.

EOF GreeceOriginal source
🇬🇧Regulatorygov.uk

The national gonorrhoea vaccination programme using 4CMenB vaccine: frequently asked questions

Answers to frequently raised questions relating to the national gonorrhoea vaccination programme usi...

UK Health Security AgencyOriginal source
🇬🇧Regulatorygov.uk

Clinical trials for medicines: MHRA phase I accreditation scheme

MHRA UKOriginal source
🇬🇧Regulatorygov.uk

Measures from the adult social care outcomes framework, England: 2025 to 2026

Findings from ASCOF, which measures how well care services achieve outcomes including quality of lif...

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

Safeguarding adults, England: 2025 to 2026 report

Official statistics on adult safeguarding concerns that were raised and where enquiries took place d...

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

Deferred payment agreements, England: 2025 to 2026 report

Official statistics on the deferred payment agreements (DPAs) that local authorities have arranged w...

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

Adult social care survey, England: 2025 to 2026 report

Official statistics on the outcomes and experiences of people aged 18 and over in receipt of long-te...

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

Healthy child programme

Resources to help keep children in England healthy, safe and well from preconception to adulthood.

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

Care continuity between midwifery and health visiting services

The importance of continuity between midwifery and health visiting services in England, and how this...

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

Unlocking the East of England’s life sciences potential: Reflections from our regional roundtable

ABPI UKOriginal source
🇬🇧Regulatorygov.uk

DHSC spending over £500

This series brings together all documents relating to Department of Health and Social Care (DHSC) sp...

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

DHSC: spending over £500, June 2026

Department of Health and Social Care spending by electronic purchasing card solution (ePCS), over £5...

UK Department of Health and Social CareOriginal source
🇪🇸Regulatoryaemps.gob.es

La AEMPS informa sobre la restricción de microplásticos y sus implicaciones para los productos biocidas de su competencia

AEMPS (Spain)Original source
🇧🇪Regulatoryfamhp.be

PRAC juli 2026: nieuwe veiligheidsaanbevelingen voor anticonceptiemiddelen met desogestrel en etonogestrel en voor Litfulo

FAMHP BelgiumOriginal source
🇺🇸Regulatoryfda.gov

Ventilator Correction: Resmed Issues Correction for Astral Ventilator

Failure of an electrical component in certain Astral ventilators may cause an interruption or failur...

FDA MedWatchOriginal source
🇺🇸Regulatoryfda.gov

Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits

Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.

FDA MedWatchOriginal source
🇯🇵Regulatorypmda.go.jp

[SHINSA]English Translation of Review Report: MiSight 1 Day

PMDA JapanOriginal source
🇺🇸Regulatorysec.gov

AstraZeneca filed Form 6-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

Novo Nordisk filed Form 6-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

Amgen filed Form 8-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

Moderna filed Form 10-Q

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

Moderna filed Form 8-K

SEC EDGAROriginal source
🇺🇸Regulatorysec.gov

AbbVie filed Form 8-K

SEC EDGAROriginal source
🇺🇸Regulatoryfederalregister.gov

Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Reducing Bureaucracy and Burden for Family Assistance Programs

This final rule amends the Grants to States for Public Assistance Programs regulations, the General...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Proposed Collection; 60-Day Comment Request, Data Use Certification for the NIH Brain Development Cohorts (NBDC) Data Hub, (National Institute on Drug Abuse)

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

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027

This final rule finalizes changes and updates to the policies and payment rates used under the Skill...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

National Center for Complementary and Integrative Health; Amended Notice of Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

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

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to co...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Center for Scientific Review; Notice of Closed Meeting

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Center for Scientific Review; Notice of Closed Meetings

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov

Office of the Secretary; Notice of Meeting

Federal RegisterOriginal source