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Executive Briefing Series (formerly The Food & Drug Letter)
May 4, 2012 | Full Issue in PDF Format
Sweeping new pharmacovigilance legislation is set to take effect in the European Union in just a few short months. The regulations — which call for increased reporting of suspected drug adverse events by drugmakers, healthcare providers and, for the first time, consumers — are aimed at strengthening safety monitoring of all drugs sold in the EU, including possible counterfeit products. In anticipation, the European Medicines Agency (EMA) has released a batch of guidelines explaining what drugmakers must do to comply with such key elements of drug safety monitoring as pharmacovigilance systems and their master files, risk management plans, adverse event reporting, periodic safety update reports, postmarket studies and signal management. Among other changes, drugs that pose a high safety risk will have to carry a black symbol on their labeling and patient information leaflet. This issue of The Food & Drug Letter takes companies through the various guidelines and the EMA’s implementation plan to ease the transition to the new drug safety system.
The European Medicines Agency (EMA) has issued new guidance on key information drugmakers must submit to support the safety monitoring of all medicines authorized and registered in the EU, whether at the centralized or national level.
Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.
Under new drug safety regulations, drugmakers must have a quality system covering the organizational structure, responsibilities, procedures, processes and resources of their pharmacovigilance system.
Drugmakers must report serious adverse drug reactions within 15 days of having received an individual case safety report (ICSR), and nonserious reactions within 90 days, according to guidance on the EU’s new pharmacovigilance regulations.
For the first time, high-risk drugs subject to special monitoring must carry a “black symbol” in the product labeling.
Companies may find it easier to submit risk management plans (RMP) to different regulatory authorities in the EU, thanks to a new modular format unveiled by the European Medicines Agency (EMA) and Heads of Medicines Agencies.
The European Medicines Agency (EMA) could require multiple drugmakers to conduct a joint post-authorization safety study (PASS) if concerns about the risk of a particular compound apply to more than one drug, according to the agency.
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