European Regulators Collaborate on Health Technology Assessment


Applied Clinical Trials

The report of a joint initiative by the EMA and the EUnetHTA has been published.

The report of a joint initiative by the European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) has been published in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.

The article is entitled “Improving the contribution of regulatory assessment reports to health technology assessments—a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.” It describes the first joint project between European regulators and HTA bodies.

The joint EMA-EUnetHTA project is a response to a political recommendation to consider how the assessment of the effects of a medicine as contained in the EMA’s European Public Assessment Reports (EPARs) can best be used to inform the assessment of the relative effectiveness of new medicines for HTA purposes in EU Member States.

“With the improved presentation of data and information in the EPAR it is envisaged that this regulatory document through harmonized efficacy data presentation will be more useful in the context of rapid relative effectiveness assessments by HTA bodies when they inform policy makers and healthcare decision makers in the future,” the authors noted.

The EMA and EUnetHTA are continuing to explore other areas of collaboration or exchange of information. These include ways for sponsors to obtain scientific advice or early dialogues with regulators and HTA or payer bodies, discussions and exchange on scientific and methodological guidelines, exploring opportunities of exchange on regulatory assessments in view of subsequent health technology assessments, post-licensing data generation, and the specificities of orphan medicinal products. Regular meetings are held between EMA and EUnetHTA, most recently on May 15, 2014. Minutes from these meetings are made available on the websites of both the EMA and EUnetHTA, as is the joint three-year work plan.

Read the full release here.

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