UK MHRA will accept SUSARs in e-format only from 1 Sept
This article was originally published in SRA
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...
Study sponsors still using the MHRA’s eSUSAR website for trial safety reporting are being urged to update their processes by 30 September.
The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.