The Medicines and Healthcare products Regulatory Agency (MHRA) today hosted an expert stakeholder forum to develop a future roadmap for the Yellow Card Scheme, as the adverse reaction reporting system celebrates its 50th anniversary.

In 1964, in the wake of the thalidomide disaster, the Yellow Card Scheme was established in the UK to collect suspected adverse drug reactions (ADRs) to provide an early warning of possible hazards. The scheme allows health professionals, patients, parents and carers to report suspected ADRs on a voluntary basis alongside those collected from the pharmaceutical industry. To coincide with the 50th anniversary of the Scheme, a new single reporting website has just been launched to support increased reporting and awareness.

Over 750,000 Yellow Cards have been received since the scheme’s inception. It has been estimated that only 85% of healthcare professionals, the largest group of Yellow Card reporters who have a responsibility to report adverse drug reactions, are aware of the Scheme.

Speaking at the event where he launched the new Yellow Card website, Life Sciences Minister George Freeman said:

“The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years. The new website updates the scheme for the 21st century, which will improve safety reporting and ultimately better protect people’s health.”

Around 25,000 ADR reports are received each year, about 7% directly from patients who have been reporting since 2005 and who continue to play a valuable role in helping MHRA in its role as the UK’s medicines and medical products regulator. 

At today’s forum, MHRA signed up to NHS England’s Sign up to Safety Campaign. Sign up to Safety is designed to help realise the ambition of making the NHS the safest healthcare system in the world and in 3 years aims to reduce avoidable harm by 50% and save 6,000 lives.

Dr Suzette Woodward, National Campaign Director, Sign up to Safety said:

“I am thrilled that the MHRA has committed to join Sign up to Safety. The MHRA supports the NHS to improve the health and safety of millions of people who use it every day, so to have them helping us achieve our aim to reduce harm and save lives is vital.”

MHRA Chief Executive Officer, Dr Ian Hudson, added:

“It is absolutely right that MHRA signs up to the campaign. There is an ever-increasing public and media interest in the availability of medicines and their safety, new medicines are delivered more rapidly to the market place than ever before, and more medicines are available without a doctor’s prescription. As we seek to embed a philosophy of reporting into the healthcare system and through better education, the number of Yellow Card reports must continue to rise.

“I’d like to thank my colleagues, particularly in the Vigilance and Risk Management of Medicines Division and everyone who has attended today’s event whose enthusiasm and expertise will shape the agency’s innovative and cost-effective approach to meet its fundamental objective of protecting public health.”

The new Yellow Card website can be found at


Posted on the UK MHRA website on 25 November 2014