Position Papers

11 Dec 2019

EBE-EFPIA Reflection Paper: Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product)

Article 117 of the Medical Device Regulation (EU) 2017/745 (MDR) requires the Marketing Authorization Applicant to include a Notified Body Opinion on the device constituent, part of a single integral...

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15 Oct 2019

EBE Position Paper: “A Risk-Based Approach to Identity Sampling of Biological Drug Substances”

Good Manufacturing Practices require that the identity of materials received for use in the manufacturing of drug products is confirmed. However, the direct sampling of primary containers of biologica...

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26 Aug 2019

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device Combination Products

Prefilled, non-reusable, integral drug-device combinations (DDCs) are regulated as medicinal products, if the intention is to administer the medicinal product to the patient. However, the device compo...

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12 Aug 2019

EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Clinical Requirements for Prefilled, Single-Use, Integral Drug-Device Combination Products

Prefilled, single-use, integral drug-device combinations (DDCs) are regulated as medicinal products. However, the device component needs to conform with “relevant” General Safety and Performance R...

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12 Jun 2019

EBE Reflection Paper: Medicinal product incorporating a drug delivery device component: An Industry Perspective on developing an efficient, ‘End to End’ Control Strategy

A cross-industry working group within EBE (European Biopharmaceutical Enterprises) has recently focused on EU specific topics relating to those integral combination products which are regulated as med...

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17 Dec 2018

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

Brussels, 17 December 2018 Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products including advanced therapy medicinal products (ATMPs) requ...

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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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