News Archive

MHRA - August MHRA News

3rd September 2025

The essential industry newsletter where we update you on our most recent activities.

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MHRA - Consultation on statutory fees: proposals on ongoing cost recovery

3rd September 2025

Government response, released 2nd September 2025.

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MHRA Safety Roundup

3rd September 2025

August 2025

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Consultation: Proposed TGA Annotations to ICH E6(R3)

2nd September 2025

This consultation invites feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period.

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MHRA launches Route B notification pilot as part of clinical trials regulations rollout

29th August 2025

MHRA launches Route B notification pilot as part of clinical trials regulations rollout.

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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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