EMA prepares new system for detecting adverse drug reactions
06.03.2012 - The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance measures to give every patient living in an EU member state the chance to report adverse drug reactions (ADRs) to their respective national regulatory authority.
An information campaign on direct reporting will be launched by the EMA and member states later this year. Preparations to implement the new pharmacovigilance rules (Regulation (EU) No 1235/2010 and Directive 2010/84/EU – adopted in December 2010) will begin in mid-July. The new rules will create many additional documentation tasks for drug developers and the Agency.
Up to now, the EMA has focussed its post-marketing drug safety monitoring on the 568 centrally-authorised medicines for human use. But starting this year, the EU drug watchdog will step-by-step also include pharmacovigilance data from nationally authorised medicines. The London-based drug experts estimate the new responsibility will mean having to cope with at least 80,000 additional ADR reports per year. About 3,000 analyses will come in from the detection of new safety signals from EU-approved medicines, while a further 624 post-marketing safety studies per year will have to be assessed.
“New rules governing the monitoring, identification and assessment of adverse events caused by pharmaceuticals will be launched in Europe in July 2012,” announced the EMA. A new committee named PRAC (Pharmacovigilance Risk Assessment Committee) will be responsible for the implementation of the new drug safety rules – and it has an ambitious working plan. First of all, PRAC will implement a procedure for protocol approval of safety studies on drugs that have already been approved at the EU level. Second, the committee will establish a process for the coordination of pharmacovigilance inspections. Third, it will revise the process for the detection of adverse drug signals so that data inputs from nationally approved medicines can be included.
Following meetings with the industry, the EMA is expected to publish details soon on the requirements for the electronic submission of a revised pharmacovigilance system master file. However, electronic submission of the safety data will have to be in place by 2015 at the latest. Until detailed guidance from PRAC is available, the EMA has published provisional information to help companies navigate through the new rules (“Information on transitional arrangements for pharmacovigilance legislation”). Additionally, the EMA published a draft concept paper defining Good Pharmacovigilance Practice (GVP).