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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.