Position Papers

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...

Read more
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....

Read more
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....

Read more
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...

Read more
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...

Read more
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...

Read more
16 Jun 2016

Consultation on IMI Advanced Therapies Concept Paper

Update of 15 September 2016: The outcomes of the consultation have now been published. Update of 26 July 2016: the consultation is now closed. Thank you to all organisations and individuals w...

Read more
22 Feb 2016

EBE Briefing Paper: Biosimilarity and Comparability after Manufacturing changes: Can a biologic become a biosimilar of itself?

Biological medicines are derived from living organisms. Manufacturing changes can therefore have an impact on the properties of the biological medicine. This has led to questions whether a biological...

Read more
22 Feb 2016

EBE Position Paper: Tissue and Cells for the Manufacture of Allogeneic Medicinal Products for multiple patients and/or indications

This Position Paper sets out the challenges, and recommends clarification and convergence of donor testing requirements, development of more sensitive test methods and of international s...

Read more
08 Apr 2015

EBE-EPEMED Position Paper on Companion Diagnostics

In September 2012, the Commission proposed a framework that defines how medical devices (MDs) and in-vitro diagnostics (IVDs) may be placed on the EU market. Subsequently, the Parliament has made a nu...

Read more
1 2