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news

News from the world

11

Aug

WHO continues work on quality of medicines

The World Health Organization designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products

WHO has officially designated Health Canada, the Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan, and the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products.

With these latest designations, WHO expands the growing list of WLAs, now involving 39 agencies across the world, supporting faster and broader access to quality-assured medical products, particularly in low- and middle-income countries (LMICs)...[WHO]

24

Oct

ECHA & REACh - SMEs to apply for company size validation before making REACH submissions

The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...

24

Oct

Changes to e-submission requirements for CEP applications for 1 November 2025

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...

24

Oct

US FDA Publishes Filing Checklists to Prevent Submission Delays

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...

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