Position Papers

19 Oct 2018

EBE-EFPIA Position Paper on Next Generation Sequencing (NGS)

Next generation sequencing (NGS), also known as high-throughput sequencing, is a DNA and RNA sequencing technology which has revolutionized genomic research. Today, an entire human genome can b...

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06 Sep 2018

Joint EBE-EFPIA Position on CE Marking

A Topic Group of the joint Personalised Medicine Working Group has been developing a slide deck highlighting the position of the pharmaceutical industry on the need to consider a risk-based a...

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02 Aug 2018

EBE View on the SPC Manufacturing Waiver

The European Biopharmaceutical Enterprises (EBE) has just released its latest position paper, raising concerns on how the SPC manufacturing waiver will affect innovative biopharmaceutical companies,...

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23 Jul 2018

EBE-EFPIA Reflection Paper: An Industry Perspective on Article 117 of the EU Medical Devices Regulation and the Impact on how Medicines are Assessed

With the publication of the new Regulation on Medical Devices (MDR, Regulation (EU) 2017/745) comes an important amendment to the medicines legislation, in Article 117. As part of the marketing author...

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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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