[White Paper] Early access in the EU: a heterogeneous landscape with room for harmonisation

 In White papers

DDR is pleased to share the results of a study assessing the current EU Early Access Programmes (EAPs) harmonisation status. The article, authored by Delphine Wagner (Associate Director Regulatory Affairs at Kinesys Consulting), has been cowritten in collaboration with Kinesys Consulting Ltd, Altran, MedDay Pharmaceuticals and DDR.

Abstract: The existence of a regulatory framework that enables pre-licensing access to medicinal products on the basis of a presumed positive benefit-risk ratio undoubtedly offers timely access to potential life-saving and innovative products to patients living with diseases representing an unmet medical need. In this article, the authors resume the results of a study they performed to assess whether the current framework of regulations results in a well-harmonised approach for early-access programmes (EAPs) across the 27 member states plus the UK.

Download the article here.



Aside from collaborating on this article, Kinesys Consulting and DDR have strategically joined efforts to constitute EMA Solutions, to provide a unique platform of Regulatory and Scientific Experts to support Applicants with EMA Committee Interactions.

Do you want to learn more about Oral Explanations and Critical Assessments at the EMA? Please feel free to send an email at info@emasolutionsconsulting.com



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