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Press release: UK regulator leads innovative EU project on the use of smartphones and social media for drug safety information

Press release

Date: 5 September 2014
Time: 10:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is leading a consortium of organisations including European medicines regulators, academics and the pharmaceutical industry in a three year project to develop new ways of gathering information on suspected adverse drug reactions (ADRs).

The project, known as WEB-RADR, is in response to the rapid adoption of smartphones, apps, and social media for discussing issues with medicines and health.  

It will work to develop a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators. It will also investigate the potential for publicly available social media data for identifying potential drug safety issues. All social media data used within the project will be appropriately anonymised to protect data privacy.

In addition to reporting suspected ADRs the app could also serve as a platform to send accurate, timely and up to date medicines information to patients, clinicians, and caregivers.

WEB-RADR will also examine the value of these new tools for monitoring drug safety. It will help to develop recommendations for medicines regulators and the pharmaceutical industry internationally on how these should be used alongside existing systems.

This project is funded though the Innovative Medicines Initiative, a public private partnership between the European Commission and European Federation of Pharmaceutical Industries and Associations.

Mick Foy, Group Manager in the MHRA’s Vigilance and Risk Management of Medicines division said:

“The growing use of smartphones and tablets by patients and healthcare professionals creates a need for reporting forms to be provided on these platforms to ensure regulators receive ADR reports that are easy to access and complete.

“Additionally the recent growth of social media platforms such as Facebook, Twitter and the many specialist sites and blogs has given rise to many people sharing their medical experiences publicly on the internet.

“Such data sharing, if properly harnessed, could provide an extremely valuable source of information for monitoring the safety of medicines after they have been licensed.

“WEB-RADR will deliver recommendations for international drug safety monitoring as to how these resources should be used ethically and scientifically.”

Notes to Editor

1. The Innovative Medicines Initiative (IMI) (external link) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients.  IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe.  IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

2. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° [115632], resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.

3. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.

4. Link to Yellow Card Scheme (external link)
Page last modified: 05 September 2014