EMA Releases First Summary of a Risk Management Plan for a New Drug

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-11-2014 23:22


The European Medicines Agency (EMA) has published the first summary for the public of the risk-management plan (RMP) of a newly authorized medicine. This RMP summary concerns the medicine Neuraceq (florbetaben), which is used as a diagnostic to determine the level of  β‑amyloid plaques in the brain, describes what is known and not known about the medicine’s safety and states what measures will be taken to prevent or minimize its risks. The RMP summary may be found here.

EMA will pilot the publishing of RMP summaries for all newly centrally authorized medicines during 2014 and at a later stage will start producing RMP summaries for previously authorized medicines.

This new type of publication is a further step toward increased transparency and public access to relevant information on medicines and is one of the requirements of the new European pharmacovigilance legislation. The RMP summaries complement the information already available in the agency’s summaries of the European public assessment report (also known as EPAR summaries).

The RMP summaries are expected to be consulted by stakeholders with a professional interest in medicines, but will also be a  resource for any member of the public who would like to have more information. 

This initiative is part of the agency’s efforts to improve information about medicines for the general public. The agency recently revised its EPAR summaries based on feedback received from various stakeholders, particularly patients and healthcare professionals.

The format and content of EPAR summaries have been updated in order to make them more user friendly and to better explain the reasons that led to the approval of the medicine. In particular, changes have been made to the way a medicine’s benefit and safety profile are described, and more information is provided on the benefit-risk balance. The agency has been using this new format since 2013 for all new summaries and is also gradually updating previously published EPAR summaries.

Source: EMA


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