News Archive

FDA - Roundup 23rd Jan 2024

24th January 2024

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

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EMA - Human medicines: highlights of 2023

18th January 2024

In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.

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EMA - Meeting Highlights PRAC 8th - 11th Jan 2024

18th January 2024

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024

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FDA Roundup: 16th January, 2024

18th January 2024

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

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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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