The EU's new legislation on pharmacovigilance officially came into force on July 2, representing the biggest change to the regulation of medicines in Europe since the European Medicines Agency (EMA) was set up in 1995.
New rules governing the monitoring, identification and assessment of adverse events caused by pharmaceuticals are introduced, with the aim of making the EU-wide system for overseeing drug safety and 'benefit-risk' more transparent and robust.
"We need smart regulation for the system to be able to continue to deliver safe and effective medicines," said the EMA's executive director Guido Rasi.
"The new pharmacovigilance legislation … gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines," he added.
Among the measures introduced are new powers for the EMA, allowing the agency to ask for post-marketing safety and efficacy studies, and the creation of a Pharmacovigilance Risk Assessment Committee (PRAC) that is scheduled to hold its first meeting on July 19-20.
Access to the PRAC's meetings, agendas and minutes will be open to the public, in a manner akin to the advisory committees operated by the US FDA, and a modified procedure for pharmacovigilance inspections will also be developed in the coming months.
Some medicines, notably biosimilars and biologics, will be subject to additional monitoring requirements and a revised process for the detection of risk signals in medicines for nationally authorised products also gets underway.
Meanwhile, pharma manufacturers will be required to prepare a pharmacovigilance safety master file (PSMF) describing their internal monitoring and control systems, and risk-management plans in a set format are now mandatory for all new marketing authorisations. Pharma companies are understood to have been hiring additional staff to cope with the incoming changes.
The definition of an adverse drug report (ADR) has also been widened to include medical error, off-label use, drug abuse and drug mis-use, and patients across Europe will now be able to report ADRs directly to regulatory authorities.
In time, other changes to the scheme will also be introduced. The EMA has already announced a system of user fees to fund its pharmacovigilance operations, and circulated a concept paper for comment earlier this month on the proposed structure and level of those fees. Previously these operations were funded publicly.
The new pharmacovigilance rules are one part of the three-pronged 'pharmaceutical package' agreed by the European Commission in 2010, alongside legislation on falsified medicines and information for patients.
"The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent," said Rasi.
- Meanwhile, the EMA has finalised its updated guideline on the processing of renewals in the centralised procedure in order to bring the document into line with the new pharmacovigilance legislation. It applies to all renewal applications submitted as of July 2.