The European Medicines Agency (EMA) on Mar. 11 launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014.
The initiative currently applies to all newly approved drugs, but will eventually be expanded to include RMP summaries for previously authorized drug products, the agency said.
The RMP summary for Piramal Imaging’s molecular imaging agent NeuraCeq (Florbetaben 18F) is the first to be released publically by the EMA, and it highlights safety concerns and steps Piramal has taken to minimize risks associated with its use.
The summary includes agency analyses of the product’s “unknowns relating to treatment benefits,” describing scenarios in which the radiopharmaceutical may not work as indicated. The drugmaker’s postmarket safety plans are also included in the summary.
The report also goes over the treatment benefits of NeuraCeq, indicated for positron emission tomography imaging of beta-amyloid neuritic plaque density in the brains of patients with cognitive impairment under evaluation for Alzheimer’s and other diseases.
This pilot program is part of the EMA’s larger initiative to increase transparency and provide more information on approved drugs to the general public — requirements from the EU’s 2010 pharmacovigilance legislation.
Late last month, the agency released guidelines requiring drugmakers in the EU to create a program to assess the effectiveness of their risk minimization efforts for each marketed drug. Companies are asked to describe the postmarket program in their product RMPs.
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