Yellow Card Scheme

(asked on 6th June 2023) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to his Answer of 5 June 2023 to Question 186944 on Yellow Card Scheme, which international mandatory reporting systems have a (a) better reporting rate and (b) more successful system for detecting safety signals than the United Kingdom, and if he will publish the MHRA review of global approaches to mandatory reporting in other regulatory systems.


Answered by
Will Quince Portrait
Will Quince
This question was answered on 13th June 2023

VigiBase is the World Health Organisation's (WHO) global database of reported potential side effects of medicinal products, and in the latest annual report, published by the WHO's Uppsala Monitoring Centre, it shows that the United Kingdom is the third largest contributor of reports, behind the USA and Germany and also one of the highest reporting countries per million inhabitants.

A working group of the International Coalition of Medical Regulatory Authorities prepared a report led by the Medicines and Healthcare products Regulatory Agency (MHRA) which provides an overview of the information provided by the participating regulatory authorities in 2018. The report includes the information collated on mandatory reporting and reporting rates.

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