BRUSSELS, Belgium and WASHINGTON, DC, September 27, 2016 – The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, has submitted written comments in response to the European Commission (EC)-issued targeted stakeholder consultation document on the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicine Products (ATMP).
The consultation document is of critical importance to all those involved in the manufacture of ATMPs, representing the large majority of ARM’s member organizations, including many small- and medium-sized enterprises and large pharma organizations, contract manufacturing organizations, academic/research institutions and more.
“We commend the European Commission in its efforts to provide specific guidance to ATMP developers,” said Annie Hubert, ARM’s director of European public policy. “Successfully industrializing and commercializing potentially transformative and life-saving advanced therapies depends on the creation and implementation of clear and appropriately defined manufacturing guidelines.”
Last November, ARM submitted comments to the 2015 version of the consultation document. In its comments, ARM acknowledges the EC for incorporating many of its suggested changes in this updated and expanded draft guidance; however, its concerns regarding the creation of a standalone guidance document on GMP for ATMP were not addressed.
In its comments, ARM recommends that the EC provide ATMP-specific guidance as an annex to the EudraLex Volume 4 of the “Rules Governing Medicinal Products in the European Union,” rather than as a separate, standalone document.
Among several concerns outlined, ARM reasons that the creation of a standalone document may lead to disparities in GMP standards, creating unnecessary confusion for companies with ATMP and non-ATMP product portfolios, as well as presenting challenges to the Competent Authorities at the time of inspection. In addition, ARM is concerned that for those organizations developing ATMPs that may be less experienced in GMP and licensing requirements, the existence and adherence to two separate GMP reference documents could lead to disparate practices, resulting in different quality standards.
“Clearly, the ATMP field is delivering some novel and very promising therapies. It is also rapidly evolving and we appreciate the Commission’s work to support the field by the provision of additional guidance for the developers of ATMPs. We would very much like the opportunity to work with the Commission to further refine the guidance to ensure it meets the specific needs of the field,” Jacqueline Barry, director of regulatory affairs, Cell and Gene Therapy Catapult and chair of ARM’s European Regulatory Affairs committee.
ARM’s submitted comments are available here.
The EC has stated it will take into account comments received to finalize the Guidelines on Good Manufacturing Practice specific to ATMP. The period of stakeholder consultation was open from June 28, 2016 to September 26, 2016. The consultation document is available here.
For more information about ARM, please visit www.alliancerm.org.
About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of transformational treatments and cures for patients worldwide. By leveraging the expertise of its membership, ARM empowers multiple stakeholders to promote legislative, regulatory and public understanding of, and support for, this expanding field.
ARM convenes various stakeholders with an interest in regenerative and advanced therapies to provide a unified voice for our 250+ member organizations, including companies – especially small- to medium-sized enterprises (SMEs); academic/research institutions; non-profit organizations; patients; and other members of the advanced therapies community. ARM’s aim is to connect all parts of the innovation lifecycle to address the unmet medical needs, particularly through supporting commercialization objectives via legislative and policy frameworks that enable next-generation therapies to reach those who need them. To learn more about ARM, visit http://www.alliancerm.org.
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