Drug approvals and regulatory pipeline
Track approvals, safety notices, guidance, label changes, and agency-driven pipeline movement.
66 visible updates from 20 agencies and publishers.
Guidance: COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Social media campaign urges Brits to get vaccinated for winter
Government launches a social media campaign to promote a new NHS App feature which helps people check their eligibility and book their flu vaccination
Jennifer Byrne Honored with 2026 Christine K. Pierre Site Impact Award
Opportunities for patients and the public to be involved in the work of the MHRA
How we engage and involve patients and the public in our regulatory decision-making.
COVID-19 vaccination: vaccine product information
Information on the presentation, doses and storage of COVID-19 vaccines.
La AEMPS inicia los IPT de los medicamentos que han obtenido una opinión positiva en la reunión del CHMP celebrada en julio
[SHINSA]English Translation of Review Report: Capvaxive and Ekterly
[보도참고] 식약처, 축산물 신규 수출 정보 안내
[보도참고] ‘디지털의료·건강지원기기 성능인증 제도’ KIMES 현장 세미나 및 홍보관 운영
Clinical Research Workforce Attrition is a Planning Failure with a Six-Month Delay
Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency Issues
Register of Innovative Drugs
A listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.
La AEMPS informa del cese de comercialización y la retirada del mercado de Daen Crema Depilatoria for Men
Azurion 7 Systems
Philips Azurion systems use solid-state drives (SSDs) in various PCs to store the operating system and image data and to support system functionality. Philips has identified that, during certain repair or service actions, SSDs that are not specified in the medical device file may have been installed. These SSDs may have different performance characteristics, which may include reduced reliability over time. When an SSD does not perform as intended, the symptoms depend on the PC in which the SSD i
i-STAT hs-TnI Cartridge
Abbott has identified that lots beginning with A24, A25, B25, B26, C26, and D26 may have a reduced ability to mitigate certain forms of analytical interference, including macrotroponin and heterophile antibody-related interference, due to variability associated with the alkaline phosphatase component used during reagent manufacturing. This issue may result in falsely elevated cardiac troponin I results. There is no evidence that the issue has caused falsely low results.
FP3D™ Resins
FP3D™ is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories. Each unit is supplied in a 10:1 resin cartridge containing part a resin and part b resin. FP3D™ resin bottles may have been mis-filled during the manufacturing process and inadvertently shipped without part B resin.
Femyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.
Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.
Faster clinical trials bring cutting-edge treatments to patients
Patients are set to receive cutting-edge treatments as the government hits its ambitious target to speed up clinical trials.
Government confirms indefinite recognition of CE marked medical devices
Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.
Απαγόρευση κυκλοφορίας του προϊόντος BIOTIQUEST – ANTIBIOTIC ANTIDOTE της εταιρείας ARSENE,,SIMONA PETRONELA, VASILE
Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
This consultation invites views on proposals for recognising CE marked medical devices in Great Britain.
[보도참고] 벤조피렌 초과 검출된 ‘들기름’ 회수 조치
[부처합동] 한-베트남 정상회담 후속 성과로 베트남에 K-닭고기가공품 수출 개시
Akeega
Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Ev
[보도참고] 식약처, 천연물 기반 한약·화장품·건강기능식품 분야 연구동향 함께 살핀다
[보도참고] 식약처, 의사의 의료용 마약류 주사제 셀프처방 및 투약 금지 성분 확대 추진
Working for DHSC
We offer a varied, exciting, challenging and rewarding working environment.
Decision: Parallel import licences granted in 2026
Parallel import licences granted in 2026.
Decision: Marketing authorisations granted in 2026
Marketing authorisations granted in 2026.
Boletín sobre Medicamentos Veterinarios. Julio-Septiembre 2026
Decision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
La AEMPS informa sobre un defecto de calidad en el medicamento Pedmarqsi 80 mg/ml solución para perfusión
IXCHIQ Chikungunya vaccine: UK marketing authorisation withdrawn following safety review
Following advice from the Commission on Human Medicines (CHM), the MHRA has concluded that the benefit-risk balance for the IXCHIQ chikungunya vaccine is no longer considered favourable and the UK marketing authorisation has been withdrawn.
Respiratory syncytial virus (RSV): vaccination for older adults
Information on respiratory syncytial virus (RSV) and the benefits of vaccination for adults and resources to promote the vaccination to older adults.
[보도참고] 식약처, 원발성 담즙성 담관염 치료 희귀의약품 허가
La AEMPS presenta los resultados del Instrumento de Apoyo Técnico para la implementación del Reglamento HTA
Hospital Glucose Meter Removal: Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems
Software update for StatStrip Glucose Hospital Meter Systems due to the potential for glucose results to be assigned to the incorrect patient.
Early Alert: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets
Cardinal Health Presource Kits may contain BD Alaris Pump Infusion Sets with Updated Use Instructions.
Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.
Renewal Season is Here! FY 2027 Device Establishment Registration and Listing
Agenda for November 2026 Mental Health Advisory Committee meeting
Vertex Pharmaceuticals filed Form 8-K
[보도참고] 식약처, 국제식품규격위원회(CODEX)에서 비관세장벽 해소 앞장
식약처, 화장품 점자 등 세부 표시 방법 안내
수능 앞둔 수험생 여러분, 카페인 함유 식품 섭취 시 주의하세요!
정부, 신생아·암환자 치료 의약품 등 국가필수의약품 8종 신규 지정
El uso de herramientas digitales facilita el acceso a la información sobre los medicamentos
Les analogues du GLP-1 et les doubles analogues GIP/GLP-1 : risques associés au mésusage et à l’utilisation hors indication pour la perte de poids
Garantir l’accès aux traitements aujourd’hui et préparer ceux de demain
MHRA authorises plozasiran (Redemplo) for adults with familial chylomicronaemia syndrome
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 October 2026, authorised plozasiran (Redemplo)
Lek z decyzją refundacyjną, którego pacjent nie dostanie. INFARMA apeluje do rządu o wykreślenie przepisów dopisanych po konsultacjach.
UK regulator brings new AI and MedTech agenda to AdvaMed
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) sets out its next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026.
Field Safety Notices: 5 to 9 October 2026
List of Field Safety Notices from 5 to 9 October 2026.
Beyond the Lab: SAHPRA introduces NWU students to careers in Radiation Science and Regulatory Science
19 October 2026 – “I knew about SAHPRA as a regulator, but I did not know about the Radiation Control Unit and the work they do,” reflected a final-year BSc student during the University of North West (NWU)’s School of Physical and Chemical Sciences (SPCS)... The post Beyond the Lab: SAHPRA introduces NWU students to careers in Radiation Science and Regulatory Science appeared first on SAHPRA .
COVID-19 vaccination: autumn programme resources
Information leaflet and sticker for the COVID-19 autumn vaccination programme.
17th meeting of the Conference of the Parties to the Convention on Biological Diversity (CBD COP17)
IQecg® Digital ECG
Affected IQecg® plugin software may produce incorrect ECG waveforms and inaccurate heart-rate calculations. Until corrected software is installed, users should manually assess the patient's heart rate before initiating therapeutic intervention and use the temporary workaround if the issue occurs. Midmark will coordinate installation of the corrected software.
Dantrium Intravenous (Dantrolene sodium for injection): Presence of particulate matter
Presence of particulate matter in affected lots.
Field Safety Notices: 12 to 16 October 2026
List of Field Safety Notices from 12 to 16 October 2026.
[보도참고] 식약처, 식의약 공공데이터·AI 활용 우수작 5건 선정
Diagnostic Ultrasound System Correction: Philips Ultrasound Issues Updated Use Instructions for Lumify Diagnostic Ultrasound System
A software app or transducer connection problem with the Philips Lumify diagnostic ultrasound system can result in loss of or delays in scanning functionality.
[SHINSA]Points to Consider for the Development of Companion Diagnostics Developed in Parallel with Anti-cancer Drugs(Early Consideration) and Quality-Related Considerations for Human Cell-Derived Extracellular Vesicle (EV) Products at the Time of Initial Clinical Trial Notification (Early Consideration) posted.
[보도참고] 「희귀질환 어린이 식사안전관리 지침」 마련, 2026년 정부혁신 왕중왕전 본선 진출
Importer of Controlled Substances Application: Organic Standards Solutions International, LLC
Organic Standards Solutions International, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.