News Archive

EMA - Small and Medium-Sized Enterprises Newsletter

22nd November 2023

Issue 60

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FDA - FDA Roundup: 21 November, 2023

22nd November 2023

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

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MHRA - International Recognition Procedure Updates

22nd November 2023

MHRA added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle to the International Recognition Procedure pages of it's website.

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MHRA - MHRA launches online Eligibility Checker tool for applications via the new International Recognition Procedure (IRP)

22nd November 2023

IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024

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MHRA - Performance Metrics

22nd November 2023

Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments

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MHRA - Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations

22nd November 2023

MHRA performance - Assessment of New Marketing Authorisation Applications and Variations

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MHRA Blog - Antimicrobial resistance: How we’re supporting innovative solutions to a looming global health emergency

22nd November 2023

World AMR Awareness Week (WAAW) is an annual global campaign from 18-24 November that raises awareness and understanding of antimicrobial resistance (AMR), a global health issue worsened by the misuse of antimicrobial agents such as antibiotics.

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Swissmedic - Interpretation of Annex 1

22nd November 2023

This technical interpretation focuses on some of the most important main changes of the revision 2022 of Annex 1 and also covers aspects that were already included in the previous version of this guideline and that repeatedly gave rise to questions.

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EMA - Veterinary Papers Released for Public Consultation

16th November 2023

Comments by 31st January 2024

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023

13th November 2023

Meeting highlights

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