News Archive

FDA, MHRA, Health Canada Joint Symposium Videos

29th February 2024

View the streams from last week's FDA, MHRA, Health Canada Symposium

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ICH - ICH E2D(R1) draft Guideline presentation

29th February 2024

Available now on the ICH website The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

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MHRA - Chief Executive Dame June Raine to step down later this year

29th February 2024

Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role

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MHRA new guidance to help applicants and shorten timeframes for assessment of established medicines

29th February 2024

Process changes from 1 March 2024 build on measures already implemented by the agency

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Animal and Veterinary - Consultations Open Now

26th February 2024

EMA consultations open for comment now.

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VICH - GMP for API GL60 open for consultation

26th February 2024

GMP for API

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FDA - Conducting Remote Regulatory Assessments Q&A

14th February 2024

Draft guidance, Released January 2024.

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FDA - Use of Data Monitoring Committees in Clinical Trials

14th February 2024

Draft guidance, Feb 2024.

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MHRA - The first steps towards a new framework for medical devices in the UK

14th February 2024

Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK

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MHRA Pharmacovigilance Symposium 2024

14th February 2024

28 February 2024

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