UK MHRA will accept SUSARs in e-format only from 1 Sept
This article was originally published in SRA
Executive Summary
The UK Medicines and Healthcare products Regulatory Agency will as of 1 September 2010 accept only electronic submissions of reports of suspected unexpected serious adverse reactions (SUSARs) that occur during pharmaceutical clinical trials1.
You may also be interested in...
UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues
Study sponsors still using the MHRA’s eSUSAR website for trial safety reporting are being urged to update their processes by 30 September.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.