Regulatory Agencies feed

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, segurid...

公告修正管制藥品品項(增列7-Hydroxymitragynine等3項管制藥品)

公告修正管制藥品品項(增列7-Hydroxymitragynine等3項管制藥品)

Judge’s order shuts down new vaccine schedule, ACIP itself

In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhoo...

European Sperm Bank ApS – Spender: 25011 Wasa

Der Spender/die Spendergameten wurden permanent gesperrt.

[ANZEN]Revisions of PRECAUTIONS: Triazolam, etc. posted

医薬品・医療機器・再生医療等製品の承認審査・安全対策・健康被害救済の3つの業務を行う組織。

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 In...

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 sanita...

Przekształcenie potencjału naukowego UE w sukces komercyjny mogłoby dodać 120 mld euro do gospodarki UE w ciągu 10 lat

Przekształcenie potencjału naukowego UE w sukces komercyjny mogłoby dodać 120 mld euro do gospodarki...

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 Ref...

CF Pharmtech’s ICF-001 cleared for clinic in China

CF Pharmtech Inc. has announced IND approval by China’s National Medical Products Administration (NM...

China NMPA clears IND for Akeso’s trispecific antibody

Akeso Inc.’s first-in-class trispecific antibody, AK-150, has received IND clearance from China’s Na...

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 Publicat...

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

Early Consideration is reference information and point of view at that time for promoting the practi...

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 Uni...

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「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「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」

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 pro...

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 pro...

Decision: Medical devices given exceptional use authorisations

List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes...

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 Ref...

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 Referenc...

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, bioec...

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.

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.

Medical devices: get regulatory advice from the MHRA

How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.

Standard: Implementation of medical devices future regime

Information on the new regulations for the post-market surveillance of medical devices which come in...

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 pro...

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 pr...

Access Generic Medicines Work Sharing Initiative

This is a work sharing model for the co-ordinated assessment of a generic application that has been...

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 pr...

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 Ref...

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 pre...

Pharmac widening access to a treatment for people with a rare blood cancer

China’s Qyuns moves IL-17 biologic toward first approval

Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National...

Hightide wins China NDA acceptance for oral metabolic therapy

China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutic...

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...

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

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 ver...

Decision: Advertising Investigations: February 2026

Decisions made by the MHRA following investigations into complaints about advertising for licensed m...

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 écon...

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...

[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.427 posted

医薬品・医療機器・再生医療等製品の承認審査・安全対策・健康被害救済の3つの業務を行う組織。

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)...

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 (...

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

Decision: Parallel import licences granted in 2026

Parallel import licences granted in 2026.

Decision: Marketing authorisations Granted in 2026

Marketing authorisations Granted in 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 VE...

China’s NMPA clears HBM-7575 to enter clinic in atopic dermatitis

Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval...

#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 c...

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 strat...

Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products

Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal...

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 regis...

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.

La AEMPS publica el Informe Anual sobre Farmacovigilancia Veterinaria

Generar PDF Fecha de publicación: 09 de marzo de 2026 Categoría: medicamentos veterinarios Referenci...

Informe Anual sobre Farmacovigilancia Veterinaria. Año 2025

Fecha de publicación: 09 de marzo de 2025NIPO: 134-25-020-9 Informe Anual sobre Farmacovigilancia Ve...

[SHINSA]Software as a Medical Device (SaMD) page updated

医薬品・医療機器・再生医療等製品の承認審査・安全対策・健康被害救済の3つの業務を行う組織。

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)...

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...

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

From climate risk to long-term resilience at the local level

How ISO 14092 drives climate adaptation in communities worldwide.

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 Tea...

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 t...

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 healthca...

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...

MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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 202...

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’associa...

COVID-19 test approval: how to apply

How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of t...

China’s NMPA clears China Medical System’s CMS-D008 for clinic

China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medica...

Lancement de la nouvelle application web HemoVigilance

Launch of the new online application HemoVigilance Publication date 06/03/2026 Virone.Letizia Fri, 0...

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...

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 clinica...

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

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 manufactur...

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 (hum...

Corporate report: MHRA Real-World Evidence Scientific Dialogue Programme

A programme to help decision making across the lifecycle of products, benefitting both regulatory an...

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...

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 ? »...

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 d...

New team to strengthen consumer voice

Introducing our Consumer Relations team – responsible for ensuring Pharmac works meaningfully with c...

Medicines: get scientific advice from the MHRA

A summary of the types of scientific advice available at the MHRA, the process for getting advice an...

China approves first noninvasive therapy for cervical precancer

China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s col...

UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing...

Find product information about medicines

How to get information including patient information leaflets (PILs), details on how the medicine ca...

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 eve...

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 hea...

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).

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...

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 thérap...

China clears first JAK/ROCK drug for myelofibrosis

China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadici...

Jiuyuan seeks approval of Wegovy biosimilar in China

China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmace...

Systimmune’s iza-bren hits phase III breast cancer goals in China

In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izal...

Guidance: Paclitaxel drug-coated balloons and drug-eluting stents

Recommendations from the independent Expert Advisory Group to the MHRA on the use of paclitaxel ball...

Turning the tide on cardiovascular diseases

Blog by Laurent Louette, Director Public Affairs & Country Liaison at Vaccines Europe Cardiovascular...

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...

European Sperm Bank – Spender: 8305 Glean

Der Spender/die Spendergameten wurden permanent gesperrt.