Global regulatory updates

WHO releases US$2 million in emergency funds to support health response in Lebanon, Iraq and Syria

15 March 2026, Cairo, Egypt — As humanitarian health needs continue to rise across parts of the Midd...

Conflict deepens health crisis across Middle East, WHO says

WHO Representative in Lebanon and team visit the Dekwaneh shelter in Beirut, hosting internally disp...

Statement by Dr Hanan Balkhy, Regional Director WHO Eastern Mediterranean Region Palais Briefing on Impact of the recent escalation on the health situation in EMR

6 March 2026Today, 115 million people across the Eastern Mediterranean Region require humanitarian a...

Statement by Dr Hanan Balkhy, WHO Regional Director at the Director-General’s Press Conference

5 March 2026Dear Director General, dear excellencies ministers of health and dear colleagues,The sit...

WHO Eastern Mediterranean Region and Pan American Health Organization sign agreement to strengthen hospital resilience

Cairo, Egypt, 25 February 2026 — WHO’s Regional Office for the Eastern Mediterranean (EMRO) and the...

WHO EMRO and Lebanese American University partner to advance IPC and AMR education

23 February 2026, Cairo, Egypt — The World Health Organization Regional Office for the Eastern Medit...

WHO and Boston University partner to tackle environmental-driven antimicrobial resistance in displaced communities

18 February 2026, Cairo-Egypt - The World Health Organization (WHO) Regional Office for the Eastern...

WHO validates elimination of trachoma as a public health problem in Libya

Photo credit: National Committee for the Prevention of blindness, Ministry of health LibyaGeneva | C...

WHO and Islamic Development Bank deepen collaboration to scale health investments across the region

WHO and IsDP meeting to explore enhanced collaboration and opportunities to scale health investments...

Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

Public list of companies in the UK who have had their licence/registration to manufacture or wholesa...

Guidance: Archiving and retention of clinical trial records

Information on clinical trial record retention and archiving requirements including requirements for...

Guidance: Declaration of Helsinki and Clinical Trial Regulations alignment

Information on the alignment of the amended UK clinical trial legislation with the Declaration of He...

Guidance: Clinical Trials Regulations enforcement provisions

Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, a...

Kintor’s KX-826 meets phase III endpoints in alopecia

Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the pr...

Magnosolv - Granulat

Rückruf aufgrund nicht eingemeldeter Seriennummern

CUROSURF 240, 1 vial de 3 ml (NR: 59600, CN: 778191)

Formato pdf Fecha de publicación: 19 de marzo de 2026 Nº alerta: R_13/2026 Fecha: 18 de marzo de 202...

PRAC assesses that NAION could be a very rare side effect of Ozempic, Rybelsus and Wegovy

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends that the product information for...

FAGG lanceert dashboard met actuele cijfers en statistieken voor klinische proeven

The FAMHP is launching a dashboard with up-to-date figures and statistics for clinical trials Public...

SFDA CEO Congratulates the Saudi Leadership on Eid al-Fitr

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), on his own behalf and...

Passion for pharma

Doorheen 2026 geeft pharma.be via een reeks video’s het woord aan verschillende geëngageerde collega...

ask@pharma.be

De farmaceutische industrie wil graag een antwoord bieden op de talloze vragen die je je wellicht st...

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...

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。

The EFPIA View

Past week (2) Past month (10) Past year (83) Older (1719) Past week (0) Past month (3) Past year (12...

Statements & press releases17.03.26Turning EU excellence in science into commercial success could add more than €120billion to EU economy in 10 yearsRead Article

New research for EFPIA by Charles River Associates provides the first comprehensive overview of the...

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.

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

Blog articles12.03.26Cancer care is becoming more efficient – Better outcomes without escalating costs (Guest blog)Read Article

Cancer places a substantial burden on European societies. It accounts for 23% of all deaths and arou...

Blog articles12.03.26Public-private partnerships: How the Innovative Health Initiative (IHI) is driving progressRead Article

From AMR and AI to big data and regulatory innovation, IHI projects are tackling Europe’s priority h...

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