Position Papers

15 Jan 2018

EBE reflection paper on “Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment”

Within the European Biopharmaceutical Enterprises (EBE), a working group focused on EU specific topics relating to those integral combination products, which are regulated as medicinal products but wh...

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19 Dec 2017

EFPIA-EBE White Paper: Expedited CMC Development- Accelerated Access for Medicines of Unmet Medical Need

Since 2012 there has been a focus on faster translation of scientific breakthroughs to new, high quality medicines meeting unmet medical need through a programme initially referred to as Medicines Ada...

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14 Dec 2017

The associations representing the European and British life science industry have today launched a joint policy document on the potential impact of the United Kingdom’s exit the European Union

The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launche...

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30 Nov 2017

EBE Concept Paper: Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products

Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products requires an appropriate framework to identify and focus on critical aspects that must be...

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10 Oct 2017

EBE and EFPIA call on the EU Commission and Member States to improve transparency on Hospital Exemptions for Advanced Therapies

“Therapies for the future - Exploring solutions for innovative treatments in Europe” will take place at the European Parliament  on 11 October 2017. In advance of this significant discussion...

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27 Sep 2017

ARM, EBE, EFPIA and EuropaBio jointly publish a series of proposals to streamline requirements and accelerate approvals of clinical trials with new therapies that consist of or contain Genetically Modified Organisms (GMOs) in Europe

The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio jointly publish a series of proposals to streamline requirements and accelerate approvals of clinical trials with new therapies that consist of or contain Genetically Modified Organisms (GMOs) in Europe....

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18 Sep 2017

EBE-EFPIA Set Out Policy Positions in Their Personalised Medicines Manifesto

The EBE-EFPIA Personalised Medicine Working Group have developed a Manifesto that aims to highlight policy elements that are considered essential to ensure that personalised medicines and their paired diagnostic tests, also called companion diagnostics, successfully reach patients....

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09 Mar 2017

EBE, EFPIA and IFPMA position paper “Considerations for physicians on switching decisions regarding biosimilars”

Switching describes a physician's decision to exchange one product that a patient receives for another. With the introduction of biosimilars, physicians may be encouraged to switch patients...

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12 Oct 2016

EBE Position Paper ” A Risk-based Approach to Setting Sterile Filtration Bioburden Limits”

As part of the submission supporting the request for a marketing authorisation, medicines must demonstrate that they are of appropriate quality, which often includes a demonstration of sterility.  B...

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19 Sep 2016

The European biotech ecosystem: EBE position paper recommends how to make funding go further

Brussels, 19 September 2016 The European Biopharmaceutical Enterprises (EBE) today published a White Paper that scrutinises funding available for innovative biopharmaceutical entrepreneurs in Europ...

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