PharmaRadar360

PharmaRadar360

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Global regulatory updates

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

34 stories in the current channel snapshot

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🇩🇰Regulatorylaegemiddelstyrelsen.dkTier 1 · Regulatory source

2026 deadline for submitting applications concerning clinical trials

Danish Medicines AgencyOriginal source
🌍Regulatoryifpma.orgTier 1 · Regulatory source

Statement on PABS Instrument at the ninth meeting of the Intergovernmental Working Group (IGWG 9) on the WHO Pandemic Agreement

IFPMA GlobalOriginal source
🇯🇵Regulatorypmda.go.jpTier 1 · Regulatory source

[SHINSA]Basic Principles for the Use of AI in Regulatory Activities（Early Consideration） posted.

PMDA JapanOriginal source
🇯🇵Regulatorypmda.go.jpTier 1 · Regulatory source

[KOKUSAI]PMDA-ATC Learning Videos contents have been updated

PMDA JapanOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Prospective Grant of Exclusive Patent License: Catheter-Based Intramyocardial Ablation for Treating Ventricular Arrhythmia in a Human

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of H...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

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.govTier 1 · Regulatory source

Bulk Manufacturer of Controlled Substances Application: AJNA Biosciences

AJNA Biosciences has applied to be registered as a bulk manufacturer of basic class(es) of controlle...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Importer of Controlled Substances Application: Globyz Pharma LLC

Globyz Pharma LLC has applied to be registered as an importer of basic class(es) of controlled subst...

Federal RegisterOriginal source
🇪🇸Regulatoryaemps.gob.esTier 1 · Regulatory source

La AEMPS expresa su más profundo pesar por la pérdida de su compañera Cristina Ferris Villanueva en el accidente ferroviario de Urda

AEMPS (Spain)Original source
🌍Regulatoryifpma.orgTier 1 · Regulatory source

Industry commits to continued efforts to protect biodiversity at close of COP17

IFPMA GlobalOriginal source
🌍Regulatoryacrpnet.orgTier 1 · Regulatory source

Entering Clinical Research “Changed the Direction” of ACRP Fellow’s Career

ACRP AssociationOriginal source
🇺🇸Regulatoryfda.govTier 1 · Regulatory source

Menopausal Hormone Therapies with Updated Prescribing Information

FDA Drug Safety CommunicationsOriginal source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

Working for DHSC

We offer a varied, exciting, challenging and rewarding working environment.

UK Department of Health and Social CareOriginal source
🇪🇸Regulatoryaemps.gob.esTier 1 · Regulatory source

La AEMPS actualiza la situación de suministro de los medicamentos que contienen estradiol de administración transdérmica

AEMPS (Spain)Original source
🌍Regulatoryima.isTier 1 · Regulatory source

Iceland as RMS and national applications – new slot request portal

IMA IcelandOriginal source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

Government accepts advice on spring 2027 COVID-19 vaccinations

Government confirms eligibility for the spring 2027 COVID-19 vaccination programme in line with JCVI...

UK Department of Health and Social CareOriginal source
🇨🇦Regulatoryrecalls-rappels.canada.caTier 1 · Regulatory source

Equate Ultra Strength Antacid Chewable Tablet: may contain foreign matter (metal fragments)

Affected lot may contain the presence of foreign matter (stainless steel shavings).

Health Canada Recalls and Safety AlertsOriginal source
🇪🇸Regulatoryaemps.gob.esTier 1 · Regulatory source

La AEMPS informa de un posible riesgo de atrapamiento relacionado con el uso de los asideros para cama Let’s Get Up y Let’s Get Up L

AEMPS (Spain)Original source
🇪🇸Regulatoryaemps.gob.esTier 1 · Regulatory source

El Comité de Disponibilidad de Medicamentos Veterinarios celebra su 15ª reunión

AEMPS (Spain)Original source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

MHRA Safety Roundup: October 2026

MHRA UKOriginal source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

Decision: Orphan registered medicinal products

MHRA UKOriginal source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

Td/IPV (3-in-one) teenage vaccine: VGD template

Vaccine group direction (VGD) template to support delivery of the national vaccination programme for...

UK Health Security AgencyOriginal source
🇺🇰Regulatorygov.ukTier 1 · Regulatory source

Diphtheria, tetanus and inactivated poliomyelitis vaccine: patient group direction template

Patient group direction (PGD) template to support the national diphtheria, tetanus and inactivated p...

UK Health Security AgencyOriginal source
🇺🇸Regulatoryfda.govTier 1 · Regulatory source

Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)

Product performance issue may lead to a false negative result which will delay recognition of hepari...

FDA MedWatchOriginal source
🇺🇸Regulatoryfda.govTier 1 · Regulatory source

Hospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter Systems

Update use instructions for StatStrip Glucose Hospital Meter Systems due to the potential for glucos...

FDA MedWatchOriginal source
🇯🇵Regulatorypmda.go.jpTier 1 · Regulatory source

[ANZEN]PMDA Alert for Proper Use of Drugs: Request for Proper Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists posted

PMDA JapanOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Schedules of Controlled Substances: Placement of Centanafadine in Schedule III

On July 24, 2026, the United States Food and Drug Administration (FDA) approved a new drug applicati...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; 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.govTier 1 · Regulatory source

Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice publi...

Federal RegisterOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Prosacea

Official structured record identifier: e5907672-3ee1-44d3-9c92-6345ad3f4238.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Fungicure Anti-Fungal Wash

Official structured record identifier: ba0cea2d-23ee-4725-abcf-72a62ad58176.

openFDA Drug LabelsOriginal source
🌍Regulatorymyscrs.orgTier 1 · Regulatory source

SCRS Digital Innovation Initiative Launches AI Guidance Framework for Sites

SCRS (Clinical Research Sites)Original source
🌍Regulatoryzamra.co.zmTier 1 · Regulatory source

ZAMRA REPRESENTATIVES APPOINTED TO AFRICAN MEDICINES AGENCY TECHNICAL COMMITTEES

Zambia Medicines Regulatory Authority (ZAMRA)Original source