News Archive

FDA - Annual report on the State of Pharmaceutical Quality

3rd September 2025

The annual report on the State of Pharmaceutical Quality is intended to help characterise the quality of the U.S. drug supply chain. Released 2nd Sept 2025.

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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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