Regulatory & Safety

EMA wants to make risk management for new drugs more transparent

13-Mar-2014
Last updated on 15-Mar-2014 at 10:33 GMT - By Zachary Brennan
EMA wants to make risk management for new drugs more transparent
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As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine. 

The first RMP summary is for Piramal’s Neuraceq - which is used during brain scans in patients with memory problems to determine if β‑amyloid plaques are present. The document describes what is known and not known about the medicine’s safety and states what measures should be taken to prevent or minimise its risks.

The European Medicines Agency (EMA) told in-Pharmatechnologist.com that: "There is no specific reason why Neuraceq was the first medicine for which a summary for the public of the risk-management plan (RMP) was published.

"Neuraceq was one of the medicines which was granted a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2013, when EMA started to pilot the process of writing and publishing the RMP summary documents.

"The RMP summaries for other medicines which were granted positive opinions at the same time are expected to become available shortly." 

Transparency

Publication of the document is part of its efforts to increase transparency, which is one of the requirements of the new European pharmacovigilance legislation.

That legislation aims to improve the collection of data post-authorization safety and efficacy studies.

The EMA also told us it will pilot the publishing of RMP summaries for all newly authorised medicines in 2014 and at a later stage will start producing RMP summaries for previously authorised medicines.

"There will be a fuller review at the end of the pilot phase which may result in further changes. Once we have a fuller understanding of the likely issues we will be able to broaden the process and will start publishing RMP summaries for older medicines as and when variations to their marketing authorisations result in significant changes.

"It is currently anticipated that we will start doing so at some point next year but we aren’t in a position to be more specific at the moment."

Consultation

The RMP summaries complement the public-friendly information already available in the agency’s summaries of the European public assessment report (EPAR).

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

This initiative is part of the EMA’s continuous drive 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 a particular medicine. Specifically, 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.

Related topics: Regulatory & Safety, Regulations