全球药监
季度情报报告

官方内容摘要

Affected lots have been added to the Excel sheet in the Affected Product section. The recommendations provided below have not changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage is observed.On June 10, 2026, Abiomed and Oscor sent all affected customers a letter recommending the following actions:Hospitals may continue to use existing inventory. Physicians should continue to use appropriate clinical awareness, monitoring, and patient support as needed. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA), Advertising Standards Authority (ASA), and the General Pharmaceutical Council (GPhC) are issuing a warning to businesses seeking to promote newly licensed medicines, as well as those that do not yet have a licence. We have seen recent examples of businesses promoting: pipeline products, such as newer forms of oral and injectable products used for weight management, including waiting lists for these products, and newly licensed oral GLP-1s, which are prescription-only medicines (POMs). The CAP Code is clear that medicines must have a licence from the MHRA before they are marketed (rule 12.11) and that prescription-only medicines or prescription-only medical treatments cannot be advertised to the public (rule 12.12).

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 器械。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Information about suspected side effects of e-cigarettes and how to report side effects. Medicines and Healthcare products Regulatory Agency e-cigarette Analysis Print - guidance document This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk.

影响分析

新的或修订中的技术要求可能改变研发设计、申报证据、质量标准或审评预期。 重点关联范围：药品 · 器械。

涉及职能：研发 · CMC · 临床 · 注册

官方内容摘要

COVID-19 test validation approved products Find out which COVID-19 test products have been approved. Medicines and Healthcare products Regulatory Agency Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations MS Excel Spreadsheet, 42.4 KB This file may not be suitable for users of assistive technology. Request an accessible format. If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email publications@ukhsa.gov.uk.

影响分析

新的或修订中的技术要求可能改变研发设计、申报证据、质量标准或审评预期。 重点关联范围：药品 · 器械。

涉及职能：研发 · CMC · 临床 · 注册

官方内容摘要

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. Lewin PackAMS7200DB098AMS7200D0Affected components contained within the convenience kits:Component NameCardinal Health Part NumberAligned Medical Solutions Part NumberComponent Lot NumberWebcol Large Alcohol Prep Pad51106912425K006462Full List of Affected ProductsWhat to DoApply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. Dispose of the recalled pads following medical waste policies at your institution.Request replacement product as needed. Check this web page for updates.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 器械。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

This webpage provides drug risk information which has come under review by the PMDA and the Ministry of Health, Labour and Welfare (MHLW). Information provided here is as follows: Risk information suggested by a certain amount of accumulated information of adverse drug reactions (ADR) reports or Early Post-marketing Phase Vigilance (EPPV) Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review. When evaluations are completed, the information in the table below will be deleted. You will find the results of evaluation on the “Revisions of PRECAUTIONS” webpage.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 器械 · 再生医疗。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Information on revisions of PRECAUTIONS investigation results Reference article note) Report on Investigation Ferric carboxymaltose Saccharated ferric oxide Summary of Investigation Valemetostat tosilate Summary of Investigation Sulfamethoxazole/trimethoprim Sulfamethoxazole/trimethoprim (injection) Summary of Investigation (genetical recombination) Summary of Investigation (genetical recombination） Summary of Investigation (genetical recombination) and biosimilars (genetical recombination) and biosimilars Summary of Investigation Calcium chloride hydrate (injection) Summary of Investigation Calcium gluconate hydrate Summary of Investigation (genetical recombination) Summary of Investigation Summary of Investigation

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 器械 · 再生医疗。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

List of Field Safety Notices for 8-12 June 2026

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 器械。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026 PRAC concludes evaluation of new data regarding potential risk of neurodevelopmental disorders in children born to men treated with valproate NewsHumanPharmacovigilance

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链

官方内容摘要

The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using

影响分析

该信息涉及安全信号、召回、短缺或风险沟通，可能影响持续供应、药物警戒及上市后风险管理。 重点关联范围：药品 · 生物制品 · 器械 · 食品。

涉及职能：药物警戒 · 质量 · 供应链