News Archive

MHRA - two new UK Approved Bodies to certify medical devices

2nd February 2024

MHRA announces two new UK Approved Bodies to certify medical devices

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EMA - Major update of the SME user guide

24th January 2024

The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.

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EMA - Highlights CVMP 16-17 Jan 2024

24th January 2024

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024

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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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