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News Archive
Quality Management System Information for Certain Premarket Submission Reviews
19th November 2025The Food and Drug Administration (FDA) has issued draft guidance outlining new expectations for Quality Management System (QMS) documentation in device pre-market submissions.
The Importance of Accurate GTIN and 2D Barcode Data in the Modern Healthcare Environment
19th November 2025A new blog post by the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate highlights how precise Global Trade Item Number (GTIN) and 2D barcode information are critical to patient safety and supply-chain integrity.
EMA partners with healthcare professionals & consumers for #ItTakesATeam medicine shortages campaign
13th November 2025The European Medicines Agency (EMA) has launched the #ItTakesATeam awareness campaign to emphasise that tackling medicine shortages in the EU requires collaboration among patients, professionals, and regulators
MHRA-led study finds major inconsistencies in global microbiome research
13th November 2025New international benchmarks aim to make gut microbiome studies more reliable for diagnosis and treatment.
100 Years of Protecting Patients Through Biological Standards for Medicines
15th October 2025On World Standards Day, 14th October 2025, the MHRA commemorates a century of ensuring the safety, efficacy, and consistency of medicines and vaccines through biological standards.
Dr Nicola Rose: A New Antibiotic Is Positive News – But It Will Take More to Stay Ahead of Superbugs
15th October 2025The MHRA's Interim Executive Director of Science and Research discusses the approval of gepotidacin, the UK's first new antibiotic for urinary tract infections in nearly 30 years, and the broader challenge of combating antibiotic resistance.
Veterinary Medicines Highlights – Issue 22
14th October 2025The European Medicines Agency (EMA) has released the 22nd edition of its quarterly newsletter, providing updates on veterinary medicines regulation as of October 2025.
A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors
10th October 2025The MHRA explores the unique challenges of supplying medicines to remote locations via air and sea, emphasising compliance with Good Distribution Practice (GDP).
EMA Management Board Highlights: October 2025
10th October 2025The European Medicines Agency (EMA) Management Board convened on 2nd October 2025, reviewing mid-year performance and endorsing strategic initiatives.
EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation
10th October 2025The European Medicines Agency (EMA) has released a draft reflection paper inviting public consultation on integrating patient experience data into the regulatory process.
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