Louisa Obillo

DSUR Submissions and Fees are Changing from 1 June 2024

Louisa Obillo and Mandy Budwal-Jagait, 4 April 2024 - Clinical Trials

The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless …

Decommission of eSUSAR

Louisa Obillo, 3 August 2022 - Clinical Trials, Good clinical practice

The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational …

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Recent posts

• Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
• DSUR Submissions and Fees are Changing from 1 June 2024
• Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium
• Pilot GMP Single Inspection Program
• MHRA Pharmacovigilance Symposium 2024