The European regulator is preparing to launch a new service it says will improve safety monitoring of medicines and simplify pharmacovigilance activities for more than 4,000 pharma companies.
The European Medicines Agency’s medical literature monitoring service will have a limited launch on 1 July and then a full roll-out in September.
It will see the regulator collect information on suspected adverse reactions – as they occur in medical literature – from 400 active substances, many of which are used in a high number of different products.
The EMA will scan the EMBASE and EBSCO literature reference databases, whose thousands of publications include journals such as The Lancet and the Journal of the American Medical Association (JAMA).
The information will then be entered into the EU’s adverse drug reaction, collection and management system EudraVigilance by the EMA, rather than pharma companies that are currently obliged to do this, often duplication each others efforts.
Meanwhile, individual cases will be made available to marketing authorisation holders for inclusion in their safety databases and to help companies meet their reporting obligations outside the European Economic Area.
The EMA said that when the service is fully launched in the Autumn it would make adverse reactions reporting more efficient, improve data quality, save pharma resources and support signal detection activities by national competent authorities and marketing-authorisation holders.
The new service was required as part of 2012’s wide-ranging overhaul of European pharmacovigilance procedures, which also handed the EMA new powers, allowing the agency to ask for post-marketing safety and efficacy studies, and created the Pharmacovigilance Risk Assessment Committee (PRAC).
The EMA has produced a series of training videos about the medical literature monitoring service, which cover its legal background, expected benefits and how to prepare for the changes.
As the launch of the new service nears the EMA said it would be sending updates on its implementation to the qualified persons for pharmacovigilance within companies as well as to pharmaceutical industry organisations.