BRUSSELS, Belgium and WASHINGTON, D.C. November 12, 2015 – The Alliance for Regenerative Medicine (ARM), the international organization representing the gene therapy, cell therapy and tissue engineering sectors, announced today it has submitted its comments in response to the European Commission’s stakeholder consultation document entitled, “Good Manufacturing Practice for Advanced Therapy Medicinal Products.”
“ARM and its member organizations welcome this targeted stakeholders’ consultation on the development of this ATMP targeted guidance and the willingness of the Commission to seek input from those developing these products,” said Annie Hubert, director of European public policy for ARM. “Ensuring that GMP requirements are tailored to the unique aspects of ATMPs is essential to their development.”
This stakeholder consultation document received significant interest from ARM member organizations; ARM received detailed contributions from subject matter experts from a wide variety of organizations including small- to medium-sized enterprises (SMEs), non-profit centers, manufacturing firms and large-cap R&D companies.
In its comments, ARM encourages the Commission to integrate the GMP requirements in the EudraLex Volume 4 “Rules Governing Medicinal Products in the European Union.” By including ATMP-specific requirements as an annex to the core GMP referential, rather than as a standalone document, ARM contends the publication would be a more complete and consistent guide.
ARM also emphasizes that international GMP consistency and convergence are critical in order to avoid unnecessary delays that could impact commercialization and patient access to ATMPs.
“The regulation of manufacturing is a critical area for accelerating promising cell and gene therapies,” said Jacqueline Barry, head of regulatory affairs, Cell Therapy Catapult and chair of ARM’s European Regulatory Affairs subcommittee. “Considering the scope and importance of this guidance, we suggest that, following consideration of the issues raised in this initial consultation, a further consultation would be beneficial for all parties.”
The period of consultation was open from July 23, 2015 to November 12, 2015. The Commission states that comments received will be taken into account when developing the guidelines on good manufacturing practice specific to ATMPs.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is a global, multi-stakeholder organization that promotes innovation, growth and delivery of transformative treatments or cures for patients suffering from chronic, debilitating and often life-threatening diseases, many of which are rare diseases. ARM convenes all stakeholders with an interest in regenerative and advanced therapies to provide a unified voice for our 225+ 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 needs of patients, 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.