News Article | September 27, 2017
BRUSSELS, BELGIUM--(Marketwired - Sep 27, 2017) - The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio announced today the release of their joint position paper, entitled "Possible Solutions to Improve European Regulatory Procedures for Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms." The paper advances a series of proposals to streamline the application and review processes by the relevant authorities and shorten the time before clinical trials of Advanced Therapy Medicinal Products (ATMPs) that consist of or contain GMOs with such products can be initiated. In drafting this position, the organisations' aim is to support European competitiveness in the biomedical sector, including the development of ATMPs, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety. The organisations identify several areas of concern with current GMO regulations for EU-based clinical trials and propose a number of near-, medium- and long-term solutions. These are designed to streamline a number of currently disparate and fragmented processes. Recommendations include the centralisation of information, a website designed to host the key EU-wide requirements, links to relevant authorities for GMO-containing ATMP clinical trials, guidance that would lay down the requirements and promotes harmonisation of classification and parallel (rather than sequential) reviews by the Health and GMO authorities. A key proposal calls for the creation of a "GMO Facilitation Group," comprising GMO authorities across Europe to facilitate dialogue and foster the adoption of more uniform and rapid decisions. The position paper highlights the benefit of implementing a number of these proposals in conjunction with the Clinical Trial Regulation, currently planned for 2019, to leverage the advantages of the improved legal framework. Barbara Freischem, Executive Director, EBE, said, "The ability to better co-ordinate the environmental risk assessment required under the GMO-regulations with the advantages of the new Clinical Trial Regulation would clearly help ATMP developers bring their innovative and often much needed products to patients." "Harmonized approaches to safety requirements of the GMO registration process for clinical trials would lead to better and faster patient-access to medical innovations. We welcome the dialogue among the different GMO authorities in the EU," added Ronald Jager, Director of Healthcare Biotechnology at EuropaBio. "For highly innovative medicinal products such as CAR-T cells, and many new gene therapies for the treatment of severe diseases, GMO regulations are in addition to the regulations for medicinal products and are implemented in different ways in each of the EU's Member States. This often increases the complexity and duration when receiving authorization to carry out clinical trials," said Jacqueline Barry, Chief Clinical Officer at Cell & Gene Therapy Catapult and chair of ARM's European Regulatory Committee. "We urge the relevant authorities in the different Member States to consider a harmonisation and streamlining of the GMO and clinical trial approval processes for these products, particularly with the upcoming implementation of the Clinical Trial Regulation." The paper is available for download here. About The Alliance for Regenerative Medicine The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 270 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org. About European Biopharmaceutical Enterprises (EBE): European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe. To learn more about EBE, visit: http://www.ebe-biopharma.eu/ About The European Federation of Pharmaceutical Industries and Associations (EFPIA): The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. To learn more about EFPIA, visit: https://www.efpia.eu/ About EuropaBio: EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 80 corporate and associate members and bio-regions, and 17 national biotechnology associations in turn representing over 1,800 biotech SMEs. Read more about our work at www.europabio.org.
Hallersten A.,SFL Regulatory Affairs and Scientific Communication Ltd |
Furst W.,SFL Regulatory Affairs and Scientific Communication Ltd |
Regulatory Toxicology and Pharmacology | Year: 2016
In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label. © 2016 The Authors.
Dupont-Inglis J.,EuropaBio |
New Biotechnology | Year: 2017
Five years following the publication of the EU Bioeconomy Strategy, this article discusses the state of play of the bioeconomy in Europe. Placing specific focus on Industrial Biotech, it outlines ten pragmatic recommendations from BIO-TIC [BIO-TIC, A roadmap to a thriving industrial biotechnology sector in Europe, 2015], an EU FP7 funded project completed in 2015 and coordinated by EuropaBio, comprehensively examining the hurdles to the development of a bioeconomy in Europe, enabled by industrial biotech. These include improving opportunities for feedstock producers within the bioeconomy; investigating the scope for using novel biomass; developing a workforce which can maintain Europe's competitiveness in industrial biotechnology; introducing a long-term, stable and transparent policy and incentive framework to promote the bioeconomy; improving public perception and awareness of industrial biotechnology and bio-based products; identifying, leveraging and building upon EU capabilities for pilot and demonstration facilities; promoting the use of co-products from processing; improving the bioconversion and downstream processing steps; improving access to financing for large-scale biorefinery projects; developing stronger relationships between conventional and non-conventional players. © 2017.
Smets G.,Perseus BVBA |
Alcalde E.,Syngenta |
Andres D.,Bayer AG |
Carron D.,EuropaBio |
And 11 more authors.
Environmental Sciences: Processes and Impacts | Year: 2014
The European Union (EU) Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment requires that both Case-Specific Monitoring (CSM) and General Surveillance (GS) are considered as post-market implementing measures. Whereas CSM is directed to monitor potential adverse effects of GMOs or their use identified in the environmental risk assessment, GS aims to detect un-intended adverse effects of GMOs or their use on human and animal health or the environment. Guidance documents on the monitoring of genetically modified (GM) plants from the Commission and EFSA clarify that, as appropriate, GS can make use of established routine surveillance practices. Networks involved in routine surveillance offer recognised expertise in a particular domain and are designed to collect information on important environmental aspects over a large geographical area. However, as the suitability of existing monitoring networks to provide relevant data for monitoring impacts of GMOs is not known, plant biotechnology companies developed an approach to describe the processes and criteria that will be used for selecting and evaluating existing monitoring systems. In this paper, the availability of existing monitoring networks for this purpose is evaluated. By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information. This journal is © the Partner Organisations 2014.
PubMed | SFL Regulatory Affairs & Scientific Communication Ltd and EuropaBio
Type: | Journal: Regulatory toxicology and pharmacology : RTP | Year: 2016
In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label.
Du Marchie Sarvaas C.,EuropaBio
Agro Food Industry Hi-Tech | Year: 2012
Food production and hunger have only recently re-discovered their status as high priority issues. It is widely agreed by international organisations that food production must increase by up to 70 percent by 2050 in order to feed to world's growing population. A wide array of tools and techniques will be necessary to meet this challenge, including biotechnology and other plant science innovations.