Risk management plans are among the documents to which EU citizens, especially sponsors of generic medicines, most frequently request access. The European Medicines Agency has decided to publish these in full for new medicines rather than just publishing RMP summaries.
The European Medicines Agency has finalized an initiative to provide further transparency on how the safety risks of newly approved products are managed by drug sponsors throughout a product’s lifecycle.
It will result in the EMA publishing the full text of risk management plans (RMPs) in the European Public Assessment...
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
