Position Papers

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
15 Sep 2015

EBE Concept Paper: Forced Degradation Studies for Therapeutic Proteins

Download
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
17 Feb 2015

EBE Position Paper on Companion Diagnostics (CDx) – February 2015

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...

Read more
03 Oct 2013

European Biopharmaceutical Enterprises’, EBE’s, position on European Medicines Agency’s Draft Policy for Clinical Trial Data Sharing

European Biopharmaceutical Enterprises, EBE, a specialised group of European Federation of Pharmaceutical Industries and Associations, EFPIA, represents the voice of biopharmaceu...

Read more
21 Aug 2013

EBE position paper on Biosimilars Labelling

EBE recommends that the label should be a combination of information on both the biosimilar and the reference product, we furthermore recommend that specific guidance for the labelling of biosimilars...

Read more
26 Apr 2013

EBE – EFPIA – EPEMED – EDCA position paper on Commission Proposal for a Regulation on In Vitro Diagnostic Medical Devices

EBE, EFPIA, EPEMED and EDCA believe that the Commission Proposal is an important step to ensure a harmonized approach to regulating in-vitro diagnostic medical devices across the EU. These 4 associati...

Read more
28 Mar 2013

Considerations in Setting Specifications

The purpose of the concept paper is to discuss considerations for setting of specifications for commercial biotech drug substances (DS) and drug products (DP) as part of an overall control strategy....

Read more
28 Mar 2013

EBE comments on the regulation on Advance Therapies

The paper identifies 6 consultation topics: Marketing authorisation application requirements for advanced therapy medicinal products Requirements for combined advanced therapy medicinal produc...

Read more
1 2 3 4