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More informationAssessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments
MHRA performance - Assessment of New Marketing Authorisation Applications and Variations
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.
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.
Comments by 31st January 2024
Meeting highlights
10th November 2023
The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024.
This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA).
Issue 174