News Archive

Gov UK - Disgraced company director convicted of falsifying medicine quality data

22nd March 2024

A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality in order to obtain a licence to sell the medicine in the UK.

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EC - CTD to CTR Guidance

13th March 2024

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

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EMA - DARWIN EU® continues expanding its capacity to deliver real-world data studies

13th March 2024

The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.

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EMA - Human Medicines Newsletter 178

13th March 2024

Edition 178, March 2024

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EMA - Meeting highlights from the PRAC 4-7 March 2024

13th March 2024

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

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FDA - Final Guideline: Q14 Analytical Procedure Development AND Q2(R2) Validation of Analytical Procedures

13th March 2024

Released March 2024

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FDA - Roundup 12th March 2024

13th March 2024

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

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MHRA - Equity in Medical Devices

13th March 2024

The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review

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MHRA - Med Tech Regulatory Reform blog

13th March 2024

March Edition

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EMA - Launch of new HMA-EMA catalogues of real-world data sources and studies

29th February 2024

EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.

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