EMA seeks feedback on using registries for regulatory purposes

RAPS

15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes. 

EMA dedicates most of the draft discussion paper to an overview of good registry practices and registry studies.

Data housed in registries can be useful in the regulatory evaluation of medicines, for example by providing insights into the safety and efficacy of drugs in the real world. In the past, EMA has asked companies to create registries covering specific products and made use of the data for post-approval purposes. However, EMA is yet to make extensive use of the registries public organisations create to track patients with a particular disease.

The draft discussion paper is part of EMA’s effort to make better use of the wealth of clinical data in patient disease registries. EMA drafted the paper in light of the findings of an effort to identify barriers to regulatory use of the data and a series of workshops focused on diseases including cystic fibrosis and multiple sclerosis. EMA undertook these activities after starting to focus on the topic in 2015.

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Michael Wonder

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Michael Wonder