News Archive

MHRA - MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner

1st April 2025

Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an event for the seven newly established Centres of Excellence for Regulatory Science and Innovation June Raine, MHRA Chief Executive, said: “At our CERSIs event this week, the depth of expertise was impressive and there was real excitement about the progress being made. The discussions highlighted a strong commitment to improving access to innovation for patients, shared with our partners Innovate UK, Office of Life Sciences and the MRC. Through the CERSIs, we have a major opportunity to drive advances in regulatory science in the UK – now is the time to turn that potential into action.”

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MHRA - Updates to Innovative Licensing and Access Pathway (ILAP) Guidance

1st April 2025

Updates have been made to these pages.

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MHRA - March 2025 Newsletter

28th March 2025

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

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MHRA - Performance Data

28th March 2025

Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.

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EMA - Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028

26th March 2025

EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS).

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

26th March 2025

11-13 March 2025

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EMA - interim report on the scientific advice pilot for high-risk medical devices.

26th March 2025

Added 24th March 2025

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FDA - FDA Roundup 21st March 2025

26th March 2025

An at-a-glance summary of news from around the agency:

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ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process

26th March 2025

Announced 20th March 2025 The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025. The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.9. The eCTDv4.0 Q&A v1.9 is available for download on the ICH ESTRI page for eCTD v4.0 here.

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MHRA - MHRA launches new monthly safety bulletin

26th March 2025

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