News Archive

EMA - Human Medicines Highlights - August 2025

12th August 2025

The newsletter for patients, consumers and healthcare professionals

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MHRA - MHRA Seeks Stakeholder Feedback on Revised ICH M4Q(R2) Guideline

12th August 2025

The MHRA is consulting on the updated ICH M4Q(R2) guideline to enhance pharmaceutical quality standards.

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MHRA Seeks Feedback on Health Institution Exemption Policy

12th August 2025

The MHRA is consulting on the health institution exemption to enhance patient access to innovative medical devices.

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FDA - FDA Launches PreCheck Program to Strengthen Domestic Drug Manufacturing

11th August 2025

The FDA has introduced the PreCheck programme to enhance domestic pharmaceutical manufacturing.

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FDA - Warning Letter

11th August 2025

Glenmark Pharmaceuticals (India)

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MHRA - MHRA Designated as WHO-Listed Authority: A Milestone for UK Life Sciences and Global Health

11th August 2025

The MHRA's new status as a WHO-Listed Authority enhances the UK's global health leadership.

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MHRA - Patients to Receive Medicines 3–6 Months Sooner Under 10-Year Health Plan

11th August 2025

Press release

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MHRA Blog - FDA Warning Letters

11th August 2025

Actions for licence holders following the issuing of USFDA Warning Letters.

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MHRA Blog - Summer 2025

11th August 2025

Summer 2025: Updates on Regulatory Reform and Innovation

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EMA - Clinical Trials Highlights July 2025

23rd July 2025

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU

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