Introduced in 2012, the legislation was meant to improve the collection of data on adverse event reports, as well as safety and efficacy studies. The law also aims to increase transparency and the population of the agency’s adverse event database known as Eudravigilance.
Little more than a year into its implementation, the EMA is already cheering its relative successes. Among those cited, the EMA notes that following the selection of the black triangle as the symbol for approved medicines that need further investigation, by August 2013 there were 119 drugs with the symbol on their packages. In addition, 47% of signals detected by the EMA resulted in label changes for medicines.
Under the legislation, adverse event reporting in the EU increased by 51,215 and for non-European Economic Area reports by 124,152 since implementation.
What the report fails to touch on, however, is a controversial drug safety fee plan, which industry balked at .
And despite the noted achievements, the EMA still has work to do. The agency is looking to populate the Eudravigilance database with case reports of old substances in 2015; publish the first risk management plan summaries in the first quarter of this year; and collect other behaviour changes and outcome measures beginning later in 2014.
“Implementation of [pharmacovigilance] legislation will continue through 2014 according to the prioritised implementation plan with further reflection on measuring performance especially as relates to behaviour change and impacts on public health and industry,” the EMA says.
The agency still has to publish four modules related to the legislation on public participation, continuous pharmacovigilance, international cooperation and risk minimisation measures. The other 12 modules have already been published.
The Agency will also be required to monitor scientific and medical literature for authorised medicinal products, which “relieves the pharmaceutical industry of the burden of such monitoring and data entry into the [Eudravigilance] system,” the EMA notes. A defined list of medical and scientific literature will be monitored and later published for certain listed active substances.