News Archive

MHRA - Roadmap towards the future regulatory framework for medical devices

18th January 2024

Released 9th January 2024

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SFDA - PV Inspections Report 2023

18th January 2024

1st Jan 2023 to 31st Dec 2023

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A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium

9th January 2024

13th - 15th February 2024

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FDA - FDA Authorises Florida’s Drug Importation Programme

9th January 2024

U.S. Food and Drug Administration have authorised Florida’s Agency for Health Care Administration’s drug importation programme under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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MHRA - Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnostics

9th January 2024

MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies.

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EMA/FDA - Joint Q&A on quality development and good manufacturing practice for Priority Medicines (PRIME) and Breakthrough therapy (BT) designation applications

20th December 2023

This Q&A provides medicine developers with guidance on how to address challenges associated with expedited product development, so that robust quality and manufacturing data packages will be available to support their application.

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EMA - Final version of HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028

19th December 2023

EMA are pleased to inform you that the final version of the HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028 has been published.

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