News Archive

FDA - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

8th January 2025

Open for Consultation

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PIC/S - Two guidance documents for inspectors on remote assessments

8th January 2025

"Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment.

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EMA - CTIS Newsflash, 17th December 2024

17th December 2024

Key updates on CTIS and links to useful reference materials.

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MHRA - Small and Medium-sized Enterprises (SMEs) Highlights Newsletter

16th December 2024

December 2024

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MHRA - Webinar on Modular Manufacture and Point of Care Regulations

13th December 2024

14:00 – 15:30 (GMT) on Tuesday 28 January 2025.

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EMA - Clinical Trials Highlights December 2024

12th December 2024

New newsletter released

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024

12th December 2024

Outcomes of the recent CVMP meeting

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FDA - FDA Roundup: 10th December 2024

12th December 2024

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

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ICH - ICH Q9(R1) IWG Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers

12th December 2024

Now available on the ICH website

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MHRA - MedRegs Blog, December 2024

12th December 2024

Festive reflections on Med Tech

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