Our industry uses digital media for a number of purposes including raising disease and treatment awareness, corporate awareness, clinical trial enrolment, recruitment and patient support.
With people engaging on health issues more and more online, it is essential that companies are up to date on the latest legislative requirements for monitoring medicine safety, which is typically referred to as pharmacovigilance.
The ABPI Pharmacovigilance Expert Network (ABPI PEN) published guidance on the management of safety information from company-sponsored websites in 2011 to help companies to comply with their legal obligations. In July 2012 updated European pharmacovigilance legislation came into force and the ABPI guidance has been updated to ensure it is consistent with the new legislation.
The new legislation provided some medium term certainty on the regulatory requirements for pharmacovigilance in digital media, which are largely unchanged from what they were prior to the legislative revision. As a result, the ABPI PEN has expanded the scope of the original guidance to include requirements for both company sponsored and non-company sponsored digital media.
To reflect the changes, the guidance has therefore been renamed ‘Guidance notes on the management of adverse events and product complaints from digital media’ and has been published today; it is free to download from the ABPI website.
Dr Esteban Herrero-MartinezHead of Regulatory Affairs