Regulatory pipeline
Drug pipeline & approvals
Review approvals, regulatory notices, and agency-driven pipeline updates in the same premium layout used on the homepage.
905 tracked updates • 19 agencies indexed
Regulatory stream
Latest pipeline updates
Showing 200 of 905 tracked regulatory updates
Pharmaceutical and Life Sciences Sector Task Force
The Pharmaceutical and Life Sciences Sector Task Force is a joint federal initiative led by Health Canada and Innovation, Science and Economic Development Canada. The task force will support reliable and sustainable access to pharmaceutical products for people in Canada and identify made-in-Canada solutions that drive innovation, competitiveness and long-term growth in the life sciences sector.
Medical devices: get regulatory advice from the MHRA
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Guidance: COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Decision: Parallel import licences granted in 2026
Parallel import licences granted in 2026.
Decision: Marketing authorisations Granted in 2026
Marketing authorisations Granted in 2026.
Regulation: Improving Patient Information
MHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.
New PRIME tools to accelerate development of medicines in the EU
EMA launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. After the completion of…, "Over the ten years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of…, The results of the pilot indicate that the new PRIME features promote enhanced regulatory agility and better support to developers. They also come at a crucial ti
Vacuum Bag SU Large
Leakage from the specimen container may occur.
Soft-Vu and Accu-Vu 4 FR Angiographic Catheters
AngioDynamics, Inc., is conducting a voluntary medical device field safety corrective action or recall to the end-user level based on the non-conformance of a molded hub in specific models and lots of Soft-Vu and Accu-Vu 4 fr angiographic catheters. The affected Soft-Vu and Accu-Vu 4 fr angiographic catheters being recalled (removed) contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. AngioDynamics h
La AEMPS publica el Informe Anual del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano
Generar PDF Fecha de publicación: 18 de marzo de 2026 Categoría: medicamentos de uso humano, seguridad Referencia: MUH (FV), 01/2026 A lo largo de 2025 se recibieron 40.990 notificaciones de sospechas de reacciones adversas a medicamentos, un incremento del 8,9% respecto al año anterior Las sospecha
公告修正管制藥品品項(增列7-Hydroxymitragynine等3項管制藥品)
Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process
New pathway set to synchronise licensing and value assessment decisions
Disinfectant Spray & Wipe Cleaner: Affected lots contain solution that do not meet the labelled strength
Affected lots contain solution that do not meet the labelled strength.
Allura Xper and Azurion Systems
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to: cable or connector damage (internal and/or external) internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray) foot switch connector issues resulting from missing or incorrectly applied strain relief No or intermittent X-ray could potentially result in a delay or abort of proce
Olympus Medical PK/PKS/Everest Cutting Forceps
Olympus identified inadequate supplier welding validation on several 5 mm cutting forceps models, which may cause jaw breakage during clinical use. Due to this defect, Olympus is requesting customers to return all affected products to prevent potential safety risks and ensure proper device performance.
Class 4 Medicines Defect Notification: Baxter Healthcare Corporation, Onkotrone Injection 2 mg/ml concentrate for solution for infusion, EL(26)A/14
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
Field Safety Notices: 9 - 13 March 2026
A list of Field Safety Notice for 9 - 13 March 2026
European Sperm Bank ApS – Spender: 25011 Wasa
Der Spender/die Spendergameten wurden permanent gesperrt.
[ANZEN]Revisions of PRECAUTIONS: Triazolam, etc. posted
Generic Drug Labeling Carve-Out Scorecard
By Kurt R. Karst – With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litiga…
預告修正「食品添加物規格檢驗方法－食用紅色七號鋁麗基」草案。
預告廢止「食品中動物用藥殘留量檢驗方法－歐來金得之檢驗」。
預告廢止「食品中動物用藥殘留量檢驗方法－歐來金得之檢驗」。 - 本署公告 - 公告資訊 - 衛生福利部食品藥物管理署 跳到主要內容區塊
Guidance: Get more help to apply for medicines Integrated Scientific Advice (ISA)
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
Notice of Compliance (NOC) Data Extracts
The data extract is a series of compressed ASCII text files of the Notice of Compliance (NOC) database.
Boletín del Comité de Medicamentos de Uso Humano. Febrero de 2026
Fecha de publicación: 16 de marzo 2026NIPO: 134-24-002-1 Información dirigida a profesionales sanitarios Índice Opiniones positivas para nuevos medicamentos mCombriax (Vacuna de ARNm frente a la gripe y la COVID-19) – dispersión inyectable en jeringa precargada. Ojemda (tovorafenib) – 100 mg comprim
Przekształcenie potencjału naukowego UE w sukces komercyjny mogłoby dodać 120 mld euro do gospodarki UE w ciągu 10 lat
La AEMPS informa de un riesgo relacionado con determinadas sillas de ruedas eléctricas Quirumed
Generar PDF Fecha de publicación: 16 de marzo de 2026 Categoría: productos sanitarios, seguridad Referencia: PS, 13/2026 El fabricante ha identificado que las patas delanteras podrían doblarse si el producto se utiliza fuera de las condiciones especificadas en las instrucciones de uso El uso de las
Updated Register of Certificates of Supplementary Protection and Applications
Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection Regulations.
Rybelsus – Rappel : risque d'erreurs médicamenteuses dû à l’introduction d'une nouvelle formulation
Rybelsus – Reminder: risk of medication errors due to the introduction of a new formulation Publication date 16/03/2026 lisa.beugnies Mon, 03/16/2026 - 09:51 From 1 April 2026, Rybelsus tablets (oral semaglutide) will be replaced by a new formulation that offers improved bioavailability. Both formul
European Sperm Bank ApS– Spender: 48127/ALEJANDRO
Der Spender/die Spendergameten wurden gesperrt.
[SHINSA]Points to Consider in the Clinical Development of Radiopharmaceuticals for Positron Emission Tomography Targeting Prostate Specific Membrane Antigen (PSMA PET) (Early Consideration) posted
16 March 2026Medical product alertWHO Information Notice for IVD Users 2026/01
As part of the WHO pre- and post-prequalification product review process, WHO’s Prequalification Unit conducted a special (for-cause) inspection of the quality management system (QMS) at the Manufacturing Sites from 14 to 16 October 2025. A for‑cause inspection is a non-routine inspection triggered by specific concerns or evidence of potential non‑compliance or product quality issues.
公告「骨錨釘系統」、「液體化學性殺菌劑/高度消毒劑」及「重複式經顱磁刺激治療系統」等3項醫療器材臨床前測試基準。
公告廢止「台灣檢驗科技股份有限公司(實驗室名稱：濫用藥物台北實驗室)」為本部認證之濫用藥物尿液檢驗機構。
公告修正「乳品加工食品業應符合食品安全管制系統準則之規定」
公告修正「乳品加工食品業應符合食品安全管制系統準則之規定」 - 本署公告 - 公告資訊 - 衛生福利部食品藥物管理署 跳到主要內容區塊
公告修正「水產加工食品業應符合食品安全管制系統準則之規定」，並自即日生效。
公告修正「罐頭食品工廠應符合食品安全管制系統準則之規定」，名稱並修正為「熱殺菌密閉容器包裝低酸性食品及酸化食品工廠應符合食品安全管制系統準則之規定」
Public Alert No. 020/2026 -Alert on Unregistered ViroActive+ Drug Purported to Cure HIV
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare providers, patients, and the public about a report concerning the circulation of unregistered ViroActive+ Capsules in Nigeria. This report was received as a complaint in the Bauchi state NAFDAC office. T
Public Alert No.019/2026 – Alert on Mop up of all Otrivin Nasal Drops (0.05% and 0.1%)
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare providers and the public about a report concerning the circulation of counterfeit and unregistered Otrivin Nasal drops (0.05%) for children and (0.01%) for adults in Nigeria. The Post Marketing Surveilla
Decision: Medical devices given exceptional use authorisations
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
La AEMPS informa de posibles retrasos al utilizar la versión 1.x de la aplicación myPTM que interactúa con la bomba implantable SynchroMed
Generar PDF Fecha de publicación: 13 de marzo de 2026 Categoría: productos sanitarios, seguridad Referencia: PS, 12/2026 El fabricante ha identificado que, al igual que ocurre con la versión 2.x de la aplicación, la versión 1.x de myPTM también puede experimentar retrasos en la pantalla de confirmac
EMA Management Board: highlights of March 2026 meeting
EMA annual report 2025The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104…
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for AviGate S. Infantis, for active immunisation of…
La AEMPS inicia los IPT de los medicamentos que han obtenido una opinión positiva en la reunión del CHMP celebrada en enero
Generar PDF Fecha de publicación: 13 de marzo de 2026 Categoría: medicamentos de uso humano Referencia: IPT, 02/2026 Los informes de posicionamiento terapéutico elaborados corresponderán tanto a los nuevos medicamentos como a las nuevas indicaciones o modificaciones de estas que hayan obtenido el vi
Natac ranks among the 20 companies with the highest return in Horizon Europe04/03/2026Access to innovationThe company is the leading private entity in financing in Extremadura and in Cluster 6 - Food,…Partners - Natac Group
The company is the leading private entity in financing in Extremadura and in Cluster 6 - Food, bioeconomy, natural resources, agriculture, and environment of the European Union's research and innovation program.
ORYZON expands patent protection for iadademstat with grant decision in Mexico covering combinations with PD-1/PD-L1 inhibitors12/03/2026Healthcare Advanced therapies Industrial biotechnologyKey combination for the treatment of Small Cell Lung Cancer.Partners - Oryzon Genomics
Key combination for the treatment of Small Cell Lung Cancer.
Instinct® Plus Endoscopic Clipping Device
Cook Medical has received 486 complaints of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle. The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire. The clip will extend from the catheter, but it will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs. Corrective actions have been implemented to miti
Arjo Tenor Mobile Lift
A supplier‑related brake component defect in the Tenor lift actuator may cause loss of self‑locking and sudden uncontrolled descent under load. All affected units must be removed from use immediately and remain out of service until actuator replacement is completed by authorized Arjo service personnel.
Monoject™ 1mL Luer Lock Syringe, Tuberculin Print, Sterile
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however, the syringes contained within the packages are U-100 Insulin syringes.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 March 2026
PRAC warns about known risk of aseptic meningitis with chikungunya vaccine IxchiqUpdate to product information recommended to reflect recent evidenceEMA’s safety committee (…, Agenda Agenda of the PRAC meeting 9-12 March 2026Draft Reference…, PRAC statistics: March 2026 , PRAC statistics: March 2026 English (EN) (10.77 MB - PDF)First published…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known assoc
[IBENTO][IBENTO]Report of APEC CoE Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2026
[SONOTA]Recent Publications by PMDA Staff updated
Pharmac seeks feedback to make access to medicines clearer and simpler for people with exceptional clinical circumstances
Protection against designer drugs: Further psychoactive substances prohibited
New synthetic drugs can harbour considerable health risks
Decision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
Standard: Implementation of medical devices future regime
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Class 2 Medicines Recall: Rokshaw Limited Trading as Curaleaf Laboratories, Curaleaf Oil [FS] 10mg/ml THC, 10mg/ml CBD (30ml), EL(26)A/13
Curaleaf Laboratories are recalling three batches of Curaleaf Oil [FS] 10mg/ml THC 10mg/ml CBD (30ml) due to low THC content.
Public Alert No. 018/2026 – Alert on Counterfeit and Unregistered Cerelac Found on Sale
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare providers, caregivers, and the public about reports of suspected counterfeit and unregistered CERELAC Mixed Fruits and Wheat products being sold in Lagos State, Nigeria. Nestle Nigeria Plc, the genuine M
Public Alert No. 017/2026 – Alert on Confirmed Counterfeit of Herceptin 600 mg in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals and the public of a confirmed counterfeit batch of Herceptin 600 mg circulating in Nigeria. This alert follows official communications from Roche Nigeria confirming a counterfeit case of H
Access Generic Medicines Work Sharing Initiative
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
Public Alert No. 015/2026 – Alert on Confirmed Counterfeit of Avastin 400mg/ 16ml and Tecentriq 1200mg/20ml in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals and the public of confirmed counterfeit batches of Avastin® 400mg/16ml (Bevacizumab) and Tecentriq® 1200mg/20ml (Atezolizumab) circulating in Nigeria. This alert is issued in response to o
La AEMPS informa de un posible desgaste prematuro en las conteras de determinadas muletas de antebrazo, bastones de aluminio ligero y conteras de goma con inserto de acero
Generar PDF Fecha de publicación: 12 de marzo de 2026 Categoría: productos sanitarios, seguridad Referencia: PS, 11/2026 El fabricante ha detectado un posible lote defectuoso de conteras de goma que podría provocar un desgaste prematuro durante su uso Este desgaste suele ser visible tras dos o tres
Product Monograph Brand Safety Updates
Product Monograph Brand Safety Updates for Submissions cleared between 01-02-2026 and 28-02-2026
Illumina launches TruPath Genome, setting a new standard in genomic insight04/03/2026HealthcareTruPath™ Genome offers more complete genome, with the simplest sample to sequencer workflow. Data…Partners - Illumina
TruPath™ Genome offers more complete genome, with the simplest sample to sequencer workflow.Data presented at AGBT demonstrates TruPath Genome's accuracy in detecting rare genetic disease.Broad Clinical Labs is among first to adopt product, which was previously known as "constellation mapped read technology".
Cream Chargers: Sold for Inhalation Without Market Authorization (DIN)
The affected product(s) are sold for inhalation without market authorization (DIN) in Canada.
The £1.4bn opportunity: How reclassification can transform healthcare, improve access to medicines and enable growth
Expanding medicine reclassification could improve access to treatments, empower self-care, and reduce pressure on NHS services.
Class 3 Medicines Recall: Bayer Plc, Various Products, EL(26)A/12
Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.
MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults
As with any medicine, the MHRA will keep the safety and effectiveness of deuruxolitinib under close review.
Pharmac widening access to a treatment for people with a rare blood cancer
List of New Drugs approved in year 2026 to till date
[Approved New Drugs] 2026-Mar-12
Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities
An updated version of Health Canada's list of established Acceptable Intake limits for N-nitrosamines (Appendix 1) has been posted online.
IntelliVue MX Patient Monitor System-IntelliBridge Module EC10
Potential safety issue concerning IntelliVue Patient Monitor (host monitor) with IntelliBridge EC10 Module and EC5 ID-Module interfacing with the Hamilton ventilator failing to alarm for "No Device Data" INOP.
Comment répondre à l’urgence pour repenser le système de santé que nous souhaitons demain ? Le Leem lance une concertation nationale afin de recueillir des propositions pour préserver l’accès aux médicaments pour tous
Comment répondre à l’urgence pour repenser le système de santé que nous souhaitons demain ? Le Leem lance une concertation nationale afin de recueillir des propositions pour préserver l’accès aux médicaments pour tous Julien Gougerot mer 11/03/2026 - 12:03 Un sondage auprès des professionnels de san
Cryos International - Aarhus ApS– Spender: Agnus
Der Spender/die Spendergameten wurden gesperrt.
Funding change will ensure more consistent emergency care for New Zealanders
公告115年度特殊營養食品查驗登記業務委託「財團法人醫藥品查驗中心」審查
公告115年度國產維生素類錠狀膠囊狀食品查驗登記業務委託「財團法人台灣食品產業策進會」審查
公告115年度基因改造食品原料查驗登記業務委託「財團法人食品工業發展研究所」審查
CHMP Meeting Highlights Februar 2026
Aktuelles aus dem Meeting vom 23.02.-26.02.2026 zu Neuzulassungen, Indikationserweiterungen, neu veröffentlichten EPAR's und kürzlich gestarteten Verfahren.
Decision: Advertising Investigations: February 2026
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
VENLAFAXINE XR: out of specification
Dissolution is out of specification in the affected batch.
Vicks Sinus Steam Inhaler (Vih200cv1)
The Vicks Sinus Steam Inhaler was distributed in Canada without the required Medical Device License (MDL) under the Health Canada medical devices regulations.
Le Leem entérine sa nouvelle gouvernance pour défendre le progrès thérapeutique et le dynamisme économique
Le Leem entérine sa nouvelle gouvernance pour défendre le progrès thérapeutique et le dynamisme économique Julien Gougerot mar 10/03/2026 - 11:59 Réunie ce mardi 10 mars 2026, l’Assemblée générale du Leem a validé par un vote la nouvelle gouvernance de l’organisation , à savoir une nouvelle composit
Global impact of UK health data resource highlighted in newly published paper
New analysis shows Clinical Practice Research Datalink has supported groundbreaking medical research across 29 countries with close to 3,800 published studies
Geef uw mening over een genetisch gewijzigd geneesmiddel tegen spierdystrofie van Duchenne
Give your opinion on a genetically modified medicine against Duchenne Muscular Dystrophy Publication date 10/03/2026 charlotte.foubert Tue, 03/10/2026 - 10:00 The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medi
[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.427 posted
Pharmac to fund life‑changing treatments for children with cystic fibrosis
10 March 2026Departmental updateSingapore sets global first by reaching WHO’s highest classification for medical device regulation
The World Health Organization (WHO) announced today that Singapore’s Health Sciences Authority (HSA) has achieved the highest level of regulatory performance for medical devices under WHO’s global benchmarking framework. Following a comprehensive assessment using WHO’s Global Benchmarking Tool Plus for medical devices (GBT+MD), HSA reached maturity level 4 (ML4), the highest classification in WHO’s system for national regulatory authorities overseeing medical products. Singapore is the first WHO
SFDA Grants Breakthrough Designation to "Bemlayo" for Adults with Obesity or Overweight
The Saudi Food and Drug Authority (SFDA) has granted Eli Lilly Breakthrough designation to Bemlayo (Orforglipron), which is indicated as an adjunct to healthy diet and physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
本署115年度研發替代役第2次徵才公告
本署115年度研發替代役第2次徵才公告 - 本署公告 - 公告資訊 - 衛生福利部食品藥物管理署 跳到主要內容區塊
Online Applications for grant of license in Form 28-D/28-DA for r-DNA products
[Circulars] 2026-Mar-10
M/s. Dr. Reddys Laboratories Limited – Altretamine IH and 26 items
[International Certificates] 2026-03-10 00:00:00.0
M/s Raks Pharma Pvt. Ltd. – Eltrombopag Olamine IH
[International Certificates] 2026-03-10 00:00:00.0
M/s Bo-Chem Private Limited, – Leflunomide BP and 6 items
[International Certificates] 2026-03-10 00:00:00.0
M/s Gold Pharma Private Limited – Apixaban IH
[International Certificates] 2026-03-10 00:00:00.0
M/s. Symed Labs Limited, Unit-l, – Ezetimibe IH/USP and 11 items
[International Certificates] 2026-03-10 00:00:00.0
Field Safety Notices: 02 to 06 March 2026
List of Field Safety Notices from 2 March to 6 March 2026.
Reunión del Comité de Medicamentos Veterinarios de marzo de 2026
Generar PDF Fecha de publicación: 09 de marzo de 2026 Categoría: medicamentos veterinarios, CODEM VET Referencia: MVET (CODEM VET) 03/2026 En esta nota se enumeran los nuevos medicamentos veterinarios de los que el CODEM-VET evaluó sus solicitudes de autorización de comercialización La próxima reuni
#NewAseBioMember “AseBio is the meeting point and the voice of the biotech sector in Spain”09/03/2026CorporateMeetELE Biotech, our new member. We spoke with Laura Vallés Saiz and Elena Calvo…AseBio - ELE Biotech
Meet ELE Biotech, our new member. We spoke with Laura Vallés Saiz and Elena Calvo Cantero, CEO and co-founder, and COO and also co-founder, respectively.
MedTech Barcelona Expands its Presence in Southeast Asia Through Partnership with i-DNA Biotechnologies09/03/2026Industrial biotechnology International CommunicationPartners - MedTech Barcelona
Barcelona - Singapore– MedTech Barcelona is strengthening its international presence through a strategic distribution partnership with i-DNA Biotechnologies, significantly expanding access to its cutting-edge ready-to-use cell-based assay kits and room-temperature shipping technologies across Southeast Asia. This collaboration represents a pivotal step in MedTech Barcelona's mission to bring innovative in vitro solutions to researchers worldwide. The partnership originated through a connection f
KETOROLAC: The weight is out of specification in the affected lots.
The weight is out of specification in the affected lots.
IXCHIQ (chikungunya vaccine, live, attenuated) and the Risk of Serious Adverse Reactions in Medically Frail Individuals 65 Years of Age and Older
Post-marketing data suggest that individuals 65 years of age and older who are medically frail with multiple chronic medical conditions may be at an increased risk of serious and life-threatening adverse reactions following recent vaccination with IXCHIQ. Audience Healthcare professionals, including physicians, pharmacists, and nurses specializing in travel or tropical medicine. Key messages Individuals 65 years of age and older who are medically frail with multiple chronic medical conditions ma
Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Clinical trials for medicines: labelling
Guidance on labelling for medicinal products used in clinical trials.
Guidance: International Council for Harmonisation (ICH) annotations
Information to help comply with ICH guidelines, if you are running clinical trials in the UK.
Clinical trials: non-investigational medicinal products
Guidance on using non-investigational medicinal products in a clinical trial.
Clinical trials for medicines: apply for approval in the UK
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Clinical trials for medicines: modifying a clinical trial approval
Guidance on the various types of modifications that can be made to a clinical trial approval.
Guidance: Clinical trials that include an in vitro diagnostic device
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Clinical trials for medicines: expert advice
Clinical trial applications that need expert advice from a specialist group or committee.
La AEMPS publica el Informe Anual sobre Farmacovigilancia Veterinaria
Generar PDF Fecha de publicación: 09 de marzo de 2026 Categoría: medicamentos veterinarios Referencia: MVET, 04/2026 En el año 2025 se han recogido un total de 3.815 notificaciones de sospechas de acontecimientos adversos a medicamentos veterinarios La mayoría de las notificaciones de acontecimiento
Informe Anual sobre Farmacovigilancia Veterinaria. Año 2025
Fecha de publicación: 09 de marzo de 2025NIPO: 134-25-020-9 Informe Anual sobre Farmacovigilancia Veterinaria. Año 2025
[SHINSA]Software as a Medical Device (SaMD) page updated
9 March 2026Departmental updateSingapore sets global first by reaching WHO’s highest classification for medical device regulation
The World Health Organization (WHO) announced today that Singapore’s Health Sciences Authority (HSA) has achieved the highest level of regulatory performance for medical devices under WHO’s global benchmarking framework. Following a comprehensive assessment using WHO’s Global Benchmarking Tool Plus for medical devices (GBT+MD), HSA reached maturity level 4 (ML4), the highest classification in WHO’s system for national regulatory authorities overseeing medical products. Singapore is the first WHO
9 March 2026List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4)List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4)
(as benchmarked against WHO Global Benchmarking Tool (GBT) (in alphabetical order)
8 January 20262025 November ACSoMP recommendations2025 November ACSoMP recommendations
Report of the Meeting of the WHO Advisory Committee on Safety of Medicinal Products, 24-25 November 2025
22 December 2025List of WHO Listed Authorities WLAsList of WHO Listed Authorities WLAs
Publications of the World Health Organization
22 December 2025List of transitional WLAsList of transitional WLAs
Publications of the World Health Organization
FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From? (Mar 4, 2015)
By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries …
From climate risk to long-term resilience at the local level
How ISO 14092 drives climate adaptation in communities worldwide.
Online Applications for Post Approval Changes (PAC) w.r.t Marketing Authorization (MA) for r-DNA products
[Circulars] 2026-Mar-09
Public Alert No. 014/2026 -Alert on Confirmed Counterfeits PHESGO 600mg With Batch Numbers B2346B16 and C3809C5
The Marketing Authorization Holder (MAH), Roche, received these complaints from Lagos University Teaching Hospital (LUTH-NSIA) reporting suspected counterfeit Phesgo® 600mg with batch numbers B2346B16 and C3809C5. The batch C3809C5 vial volume was observed to be approximately 20mL instead of the exp
Public Alert No. 013/2026 – Alert on Dietary Supplement By FDA Over Safety Concerns
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that Stuff by Nainax LLC is voluntarily recalling all lots of “MR.7 SUPER 700000’’ capsules to the consumer level over safety concerns. The recall follows an FDA analysis, which found “MR.7 SUPER 70000
Public Alert No. 012/2026 – Alert on Confirmed Counterfeit Batches of Avastin 400mg in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the healthcare providers and the public of a report of confirmed counterfeit Avastin 400mg in Nigeria. The Marketing Authorization Holder (MAH), Roche, reported that an oncologist from a local hospital expressed
Natac to participate in CBE JU Stakeholder Forum26/02/2026BioeconomyThe second edition of this high-level event will take place on March 24 in Brussels under the motto…Partners - Natac Group
The second edition of this high-level event will take place on March 24 in Brussels under the motto “Driving Impact: Bio-based innovation for a competitive, sustainable Europe”
Precautionary recall of blood pressure medication after packaging error
The MHRA has advised pharmacy and healthcare professionals to return all remaining stock to their suppliers
MHRA phase I accreditation scheme
How to join the phase I accreditation scheme.
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 5mg capsules, EL(26)A/11
Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure due to a potential error at the manufacturing site.
IKERVIS 1 mg/ml colirio en emulsion 30 envases unidosis de 0,3 ml (NR: 115990001, CN: 707966)
Formato pdf Fecha de publicación: 06 de marzo de 2026 Nº alerta: R_12/2026 Fecha: 05 de marzo de 2026 Producto: Medicamento Marca comercial, presentación, número de registro y código nacional: IKERVIS 1 mg/ml colirio en emulsion 30 envases unidosis de 0,3 ml (NR: 115990001, CN: 707966) DCI o DOE: CI
Moyen-Orient : face à l’escalade régionale et aux dégâts collatéraux de la guerre en Iran, l’association Tulipe lance un appel aux dons aux entreprises de santé
Moyen-Orient : face à l’escalade régionale et aux dégâts collatéraux de la guerre en Iran, l’association Tulipe lance un appel aux dons aux entreprises de santé Julien Gougerot ven 06/03/2026 - 14:12 L’offensive américano-israélienne en Iran a déclenché une nouvelle phase d’instabilité au Moyen-Orie
COVID-19 test approval: how to apply
How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.
Lancement de la nouvelle application web HemoVigilance
Launch of the new online application HemoVigilance Publication date 06/03/2026 Virone.Letizia Fri, 03/06/2026 - 13:11 The FAMHP is launching HemoVigilance, a new online application for reporting serious adverse reactions related to the donation or transfusion of blood and blood components. The appli
Innovation with integrity: Why NHS-industry partnerships matter, and how conflicts of interest are managed
Dr Amit Aggarwal discusses the importance of NHS-industry relationships, and the safeguards in place to ensure they always put patients and the NHS first.
For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs
Reset Programme reflects on progress to transform engagement
Obesity experts advise on new treatments
Collaboration on medical device procurement
New agreement improves access to treatment for New Zealanders
Funding medicines for people with high health needs
Implementation of Prior intimation System for Forms CT-10, CT-12 and CT-13 in pursuance of G.S.R. 46(E) dated 20.01.2026
[Circulars] 2026-Mar-06
Summary Basis of Decision for Ahzantive
Health Canada Summary Basis of Decision 2026-02-02. Ahzantive, 2 mg/0.05 mL aflibercept, solution, Valorum Biologics LLC. Submission Control Number 292152
Summary Basis of Decision for Elfabrio
Health Canada Summary Basis of Decision 2026-02-09. Elfabrio, pegunigalsidase alfa 5 mg/2.5 mL and 20 mg/10 mL, solution, Chiesi Farmaceutici S.p.A. Submission Control Number 287986
Summary Basis of Decision for Enzeevu
Health Canada Summary Basis of Decision 2026-01-19. Enzeevu, aflibercept, 2 mg/0.05 mL (40 mg/mL), solution, Sandoz Canada Inc. Submission Control Number 290401
Summary Basis of Decision for Imaavy
Health Canada Summary Basis of Decision 2026-01-31. Imaavy, nipocalimab 300 mg/1.62 mL (185 mg/mL) and 1,200 mg/6.5 mL (185 mg/mL), solution, Janssen Inc. Submission Control Number 293081
Summary Basis of Decision for mNexspike
Health Canada Summary Basis of Decision 2025-12-22. mNexspike, 10 mcg/0.2 mL nucleoside-modified mRNA, dispersion, Moderna Biopharma Canada Corporation. Submission Control Number 291323
Summary Basis of Decision for Nilemdo
Health Canada Summary Basis of Decision 2026-02-02. Nilemdo, 180 mg bempedoic acid, tablet, HLS Therapeutics Inc. Submission Control Number 291745
Summary Basis of Decision for Tevimbra
Health Canada Summary Basis of Decision 2026-02-11. Tevimbra, tislelizumab 100 mg/10 mL, solution, BeOne Medicines I GmbH. Submission Control Number 293878
Summary Basis of Decision for Tyruko
Health Canada Summary Basis of Decision 2026/02/11. Tyruko, natalizumab, 300 mg/15 mL, solution, Polpharma Biologics S.A. Submission Control Number 286523
Summary Basis of Decision for Yesintek & Yesintek I.V.
Health Canada Summary Basis of Decision January 19, 2026. Yesintek and Yesintek I.V., 130 mg/26 mL solution (5 mg/mL) ustekinumab, solution, intravenous administration. Also, 45 mg/0.5 mL and 90 mg/1 mL solution, Biosimilar Collaborations Ireland Limited. Submission Control Number 284892
Summary Basis of Decision for Zurzuvae
Health Canada Summary Basis of Decision 2026-02-19. Zurzuvae, zuranolone, 20 mg, 25 mg, and 30 mg, capsule, Biogen Canada Inc. Submission Control Number 290103
Decision: Medicines: new manufacturing and wholesale dealer licences
List of sites granted a manufacturer or wholesale dealer licence.
Decision: Human and veterinary medicines: register of licensed manufacturing sites
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Notice: Register of brokers authorised to deal in human medicines
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Decision: Human medicines: register of licensed wholesale distribution sites
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human).
Corporate report: MHRA Real-World Evidence Scientific Dialogue Programme
A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
New guidance on the conduct of clinical trials during public health emergencies in the EU
The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health…
APO-BRIMONIDINE-TIMOP: The weight is out of specification in the affected lot.
The weight is out of specification in the affected lot.
Chromophare Surgical Lighting System
Stryker has discovered that certain lots of the soffit ring may not adequately support the weight of the ceiling cover. As a result, the cover may shift or slide down the ceiling tube. Movement of the ceiling cover can expose the area above the ceiling, which may allow particles, such as dust, debris, residue, or other contaminants, to enter the sterile field.
Lifeworks Technology Vibra-Heal and Restore Massage Guns
The device was distributed in Canada without a valid class II Medical Device Licence under the Medical Devices Regulations. No safety defect has been identified. Sales ceased and a licence application is planned.
Improving diversity in clinical trials is both an equity issue and a scientific necessity
Brian Duggan reflects on the need for more inclusive research
Building momentum through the VPAG review
The latest Operational Review of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) took place in late December. In this piece, Pinchas Kahtan, ABPI's Head of Commercial Policy, shares the key points discussed and agreed at the meeting, and looks ahead to what's next f
Retour sur le colloque « Nouveaux équilibres mondiaux : quel avenir pour le médicament en France ? »
Retour sur le colloque « Nouveaux équilibres mondiaux : quel avenir pour le médicament en France ? » Julien Gougerot jeu 05/03/2026 - 11:24 Le 15 décembre dernier, le Leem a organisé à Paris un colloque intitulé « Nouveaux équilibres mondiaux : quel avenir pour le médicament en France ? ». Cette ren
Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority
UK Space Agency, MHRA, RIO and CAA set out support for in-orbit manufacturing of pharmaceuticals
UK sets out world‑leading pathway for space‑manufactured drugs
Patients could benefit from more effective, higher quality and longer lasting medicines as the UK sets out a clearer route to bring drugs manufactured in space safely to market.
PRAC februari 2026 – Het PRAC beveelt aan om geneesmiddelen die levamisol bevatten van de Europese markt te halen
PRAC February 2026 – PRAC recommends the withdrawal of medicines containing levamisole Publication date 05/03/2026 nuria.blanckaert Thu, 03/05/2026 - 09:39 During its February 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended the withdrawal of
New team to strengthen consumer voice
Introducing our Consumer Relations team – responsible for ensuring Pharmac works meaningfully with consumers.
M/s Phaex Polymers Pvt. Ltd – Calcium Polystyrene Sulfonate BP and 4 items
[International Certificates] 2026-03-05 00:00:00.0
M/s Nosch Labs Pvt Limited, Unit-IV – Siladosin IH and 28 items
[International Certificates] 2026-03-05 00:00:00.0
M/s Torrent Pharmaceuticals Limited. – Roflumilast IH and 3 items
[International Certificates] 2026-03-05 00:00:00.0
M/s Megafine Pharma (P) Limited – Vildagliptin IH and 3 items
[International Certificates] 2026-03-05 00:00:00.0
Medicines: get scientific advice from the MHRA
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Find product information about medicines
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
Contact the MHRA
How to contact the MHRA for specific services or enquiries.
Drug Product Database data extract [2026-03-02]
The Drug Product Database (DPD) extract files contain complete product information for all approved, marketed and cancelled products, for human, veterinary, disinfectant and radiopharmaceutical use.
European Sperm Bank ApS – Spender: 8979-STAN
Der Spender/die Spendergameten wurden permanent gesperrt.
Catch up with Condalab: II Digital Cell Biology Conference03/03/2026Healthcare Advanced therapiesCondalab invites you to the second edition of our Digital Cell Biology Conference, a free online…Partners - CONDALAB
Condalab invites you to the second edition of our Digital Cell Biology Conference, a free online event aimed at professionals working in biomedical or veterinary research, where cellular models and assays are becoming increasingly relevant.
Genetics drives a new stage in precision preventive medicine03/03/2026Healthcare Personalized medicineThe integration of polygenic risk models based on genome-wide association studies (GWAS) enables…Partners - ADNTRO GENETICS SL
The integration of polygenic risk models based on genome-wide association studies (GWAS) enables healthcare professionals to incorporate genetic risk stratification into clinical practice and advance toward data-driven, personalized prevention.
ORYZON reports financial results and corporate update for quarter ended December 31st, 202502/03/2026Healthcare Innovative drugs Personalized medicine Advanced therapies FinancingStrong cash position at year-end 2025: $33.3 million (€28.4 million).Partners - Oryzon Genomics
Strong cash position at year-end 2025: $33.3 million (€28.4 million).
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
There is already an inherent risk of a false pass with the DPOAE testing protocol with AccuScreen® for a child with a hearing disorder and this cannot be eliminated. This inherent risk of false negative answers was increased when deviating from the AccuScreen® factory default DPAOE Protocol (DP-1) using DPOAE Probe 8-69-41100.
Abiomed Purge Cassette Generation 1 for Impella
Abiomed, Inc. has issued a voluntary device recall (removal) of Purge Cassette (Generation 1) due to an increased risk of purge leaks. An updated Purge Cassette (Generation 2) has been developed with a lower risk of purge leaks. Abiomed is coordinating the product removal and replacement process. In the interim, when using a Generation 1 Purge Cassette Abiomed advises closely monitoring the Purge System and consulting the IFU should a 'Purge Pressure Low' alarm occur.
La AEMPS habilita de nuevo el portal de notificación de efectos no deseados relacionados con productos cosméticos
Generar PDF Fecha de publicación: 04 de marzo de 2026 Categoría: cosméticos Referencia: COS, 04/2026 Este portal permite a la ciudadanía, personas usuarias profesionales, a profesionales sanitarios, y a personas responsables y distribuidores de productos cosméticos notificar efectos no deseados al S
식약처 차장, 반려동물 동반출입 음식점 현장 방문
[보도참고] 달걀 세척·살균은 이렇게 하세요
달걀 세척·살균은 이렇게 하세요
[보도참고] 미세먼지 심한 날, 보건용 마스크 ‘의약외품(KF)’ 여부 확인하고 사용하세요
미세먼지 심한 날, 보건용 마스크 ‘의약외품(KF)’ 여부 확인하고 사용하세요
115年度提升食品安全與衛生知能活動公開徵求企劃案說明書
115年度提升食品安全與衛生知能活動公開徵求企劃案說明書 - 本署公告 - 公告資訊 - 衛生福利部食品藥物管理署 跳到主要內容區塊
預告修正「適用罕見疾病防治及藥物法之藥物品項」草案。
預告修正「適用罕見疾病防治及藥物法之藥物品項」草案。 - 本署公告 - 公告資訊 - 衛生福利部食品藥物管理署 跳到主要內容區塊
Delphine Aguiléra-Caron prend la présidence de la commission « Accès des patients aux progrès thérapeutiques » du Leem
Delphine Aguiléra-Caron prend la présidence de la commission « Accès des patients aux progrès thérapeutiques » du Leem Julien Gougerot mar 03/03/2026 - 23:47 Contacts presse : Virginie PAUTRE - 06 31 86 82 70 - vpautre@leem.org Julien GOUGEROT - 06 08 97 50 49 - Jgougerot@leem.org Actualités Le Leem
Man jailed for ten years for convictions including selling prescription-only medicines worth more than £3.7million
A man who unlawfully supplied Class B and Class C controlled drugs and a range of unauthorised medicines has been sentenced at Stoke-on-Trent Crown Court following an investigation by the MHRA’s Criminal Enforcement Unit.
Guidance: Paclitaxel drug-coated balloons and drug-eluting stents
Recommendations from the independent Expert Advisory Group to the MHRA on the use of paclitaxel balloon catheters and stents to treat peripheral arterial disease.
Human medicines: highlights of 2022
Update as of 3 March 2026This news was updated to accurately reflect the number of medicines with a new active substance recommended for marketing authorisation.In 2022, EMA…
Turning the tide on cardiovascular diseases
Blog by Laurent Louette, Director Public Affairs & Country Liaison at Vaccines Europe Cardiovascular diseases (CVD) claim over 1.8 million lives across Europe every year [1]. Behind this number are millions of people living with the daily realities of heart disease – some 62 million Europeans whose
Importation of Portuguese-authorized Lentocilin S 1200 1 200 000 IU / 4 mL, due to the current shortage of Canadian-authorized Bicillin L-A 1 200 000 IU / 2 mL
UPDATED INFORMATION – March 3, 2026 Further to the Health Canada communication below, issued on February 18, 2026, additional supply of the Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL has been made available to mitigate the ongoing shortage. This new supply is available with bilingual (English and French) labels (see images in Appendix 2 below). Given the medical necessity of Bicillin L-A 1 200 000 IU / 2 mL and the need to maintain continuity of supply in Canada, Health Canada
Field Safety Notices: 23-27 February 2026
List of Field Safety Notices from 23-27 February 2026.
La AEMPS coorganiza el evento “From collaboration to transformation: Making EU HTA a reality”
Generar PDF Fecha de publicación: 03 de marzo de 2026 Categoría: la AEMPS, HTA Referencia: AEMPS, 02/2026 La AEMPS, junto con la Comisión Europea y KPMG, ha celebrado en Madrid el evento “From collaboration to transformation: Making EU HTA a reality”, para reflexionar sobre el primer año de implemen
European Sperm Bank – Spender: 8305 Glean
Der Spender/die Spendergameten wurden permanent gesperrt.