Position Papers

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...

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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...

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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...

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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....

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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...

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01 Mar 2013

Platform Manufacturing of Biopharmaceuticals: Putting Accumulated Data and Experience to Work

Technology and process platforms are now used extensively in the biopharmaceutical industry, both throughout the various phases of product development and in the facilities used to manufacture clinica...

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18 Nov 2012

EBE and EuropaBio’s position paper on Registries and Databases for Orphan Medicinal Products

BACKGROUND AND PURPOSE OF THE POSITION PAPER Registries are well-established & commonly-used methods for tracking and reporting clinical outcome, safety, effectiveness and epidemiological endpo...

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18 Nov 2012

Position Paper for Rare Diseases and Orphan Drugs Registries and Databases

BACKGROUND AND PURPOSE OF THE POSITION PAPERRegistries are well-established & commonly-used methods for tracking and reporting clinical outcome, safety, effectiveness and epidemiological endpoints for...

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21 May 2012

EBE Position Paper on Tendering of Biologicals, including Biosimilars

The procurement practice is primarily used for medicines which are genuinely identical, bio-equivalent, multi-sourced and off-patent, i.e., small chemical molecules, so-called generics and their origi...

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31 May 2011

EBE Comments on Concept Paper on Biosimilars Containing Biotech-Derived Proteins as Active Substance

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