Regulatory Focus™ > News Articles > In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

Posted 13 March 2014 | By Alexander Gaffney, RAC

In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug.

Background: What's an RMP?

The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known risks associated with the medication.

For those familiar with the US regulatory system, elements of RMPs are similar to Risk Evaluation and Mitigation Strategies (REMS), Elements to Assure Safe Use (ETASU), Boxed Warnings and postmarketing study commitments.

But unlike the US system, which generally makes these plans publicly available, the European Medicines Agency (EMA) has not historically posted RMPs.

RMPs for the People

Not, that is, until now.

On 11 March 2014, EMA announced that it had published its first-ever public summary of an RMP for an approved medicine, Neuraceq [florbetaben (18F)], a diagnostic imaging agent intended to help diagnose Alzheimer's disease.

The RMPs "describe what is known and not known about the medicine's safety and state what measures will be taken to prevent or minimize its risks," EMA said. "The RMP summaries complement the public-friendly information already available in the Agency's summaries of the European public assessment report (also known as EPAR summaries)."

Information included in the first RMP includes an overview of the disease epidemiology, a summary of treatment benefits, "unknowns" related to treatment, summary of safety concerns, missing information, planned post-authorization studies, and a list of changes made to the RMP.

While EMA will make all subsequent RMPs publicly available, it will only start to work on making previous RMPs available at an as-yet unspecific "later date."


EMA Press Statement

First Public RMP

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