SBA Member, 27.09.2017
ATMPs and 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.
Brussels, BELGIUM, September 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 centralization 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 harmonization and streamlining of the GMO and clinical trial approval processes for these products, particularly with the upcoming implementation of the Clinical Trial Regulation” she concluded.
The paper is available for download here.
Note on signatories
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/
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.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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