TGA需人工补检：https://tga.gov.au/feeds/alert.xml: Operation timed out after 35294 milliseconds with 0 bytes received | https://tga.gov.au/feeds/article.xml: Operation timed out after 35292 milliseconds with 0 bytes received | https://tga.gov.au/feeds/guidance.xml: Operation timed out after 35291 milliseconds with 0 bytes received | https://tga.gov.au/feeds/consultation.xml: Operation timed out after 35290 milliseconds with 0 bytes receivedHTTP 301

HC已采集 14 条候选HTTP 200

ANVISA已采集 30 条候选HTTP 200

ANMAT需人工补检：https://www.argentina.gob.ar/anmat/alertas: no dated regulatory entriesHTTP 200

HSA已采集 10 条候选HTTP 200

NPRA已采集 3 条候选HTTP 200

Thai FDA已采集 10 条候选HTTP 200

BPOM需人工补检：https://www.pom.go.id/berita: SSL certificate OpenSSL verify result: unable to get local issuer certificate (20)HTTP 0

FDA Philippines需人工补检：https://www.fda.gov.ph/advisories/: HTTP 403HTTP 403

DAV需人工补检：https://dav.gov.vn/thong-bao.html: Connection timed out after 12002 millisecondsHTTP 0

DDF需人工补检：https://moh.gov.kh/: no dated regulatory entriesHTTP 200

FDA Myanmar需人工补检：https://www.fda.gov.mm/: Recv failure: Connection reset by peerHTTP 0

FDD Laos已采集 4 条候选HTTP 200

DPS需人工补检：https://moh.gov.bn/: no dated regulatory entriesHTTP 200

TFDA已采集 10 条候选HTTP 200

Drug Office需人工补检：https://www.drugoffice.gov.hk/eps/news/DrugNews: no dated regulatory entriesHTTP 200

NMRA需人工补检：https://www.nmra.gov.lk/announcements/: no dated regulatory entriesHTTP 200

CDSCO需人工补检：https://cdsco.gov.in/opencms/opencms/en/Notifications/: no dated regulatory entriesHTTP 200

Swissmedic需人工补检：https://www.swissmedic.ch/swissmedic/en/home/news.html: no dated regulatory entriesHTTP 200

Medsafe需人工补检：https://www.medsafe.govt.nz/hot/alerts.asp: no dated regulatory entriesHTTP 200

SAHPRA已采集 10 条候选HTTP 200

全球药监信息，一个入口。

监管机构与数据库

NMPA

国家药品监督管理局

CDE

国家药监局药品审评中心

FDA

Food and Drug Administration

EMA

European Medicines Agency

MHRA

Medicines and Healthcare products Regulatory Agency

PMDA

Pharmaceuticals and Medical Devices Agency

MFDS

Ministry of Food and Drug Safety

TGA

Therapeutic Goods Administration

HC

Health Canada

ANVISA

Agência Nacional de Vigilância Sanitária

ANMAT

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

HSA

Health Sciences Authority

NPRA

National Pharmaceutical Regulatory Agency

Thai FDA

Thai Food and Drug Administration

BPOM

Badan Pengawas Obat dan Makanan

FDA Philippines

Food and Drug Administration Philippines

DAV

Drug Administration of Vietnam

DDF

Department of Drugs and Food, Ministry of Health

FDA Myanmar

Food and Drug Administration Myanmar

FDD Laos

Food and Drug Department, Ministry of Health

DPS

Department of Pharmaceutical Services

TFDA

Taiwan Food and Drug Administration

Drug Office

Drug Office, Department of Health

NMRA

National Medicines Regulatory Authority

CDSCO

Central Drugs Standard Control Organisation

Swissmedic

Swiss Agency for Therapeutic Products

Medsafe

New Zealand Medicines and Medical Devices Safety Authority

SAHPRA

South African Health Products Regulatory Authority

季度监管情报

Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

Early Alert: Catheter Introducer Issue from Abiomed and Oscor

Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management

Guidance: Advice for consumers

Guidance: COVID-19 test validation approved products

Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.

Committee for Advanced Therapies (CAT) rules of procedure

Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29

June 16, 2026 Safety New PMDA Risk Communications: Omeprazole etc. posted

June 16, 2026 Safety New Revisions of PRECAUTIONS: Lithium carbonate , etc. posted

IRIS guide to registration and RPIs

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

Field Safety Notices: 8 -12 June 2026

Recall of BD ChloraPrep™ 1 mL Applicator – Clear

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication

Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026

Early Alert: Positive Pressure Breathing Device Issue from Baxter

FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

Regulation of medical devices in Northern Ireland

Regulation of AI in Healthcare

全球药监信息，
一个入口。