The Alliance for Regenerative Medicine (ARM), an international advocacy organization representing the cell and gene therapy and broader regenerative medicine and advanced therapies sector, today published its recommendations for fostering development of and patient access to advanced therapy medicinal products (ATMPs) in Europe. These proposals support and complement the European Medicines Agency’s (EMA) and the European Commission’s (EC) Action Plan on ATMPs, issued October 2017.
ARM’s recommendations, available here, elaborate on the organizations’ original proposed initiatives, emphasizing areas of priority, and address various aspects not covered in the EC/EMA Action Plan, with specifics for next steps.
“ARM greatly values the work of the EMA and EC to try to improve the regulatory environment for ATMPs in Europe,” said Jacqueline Barry, Ph.D., Chief Clinical Officer of Cell and Gene Therapy Catapult. “ARM and its members hope to provide further input and clarification as to what is necessary to support the continued innovation this sector brings and to ensure these important products reach patients in need.”
ARM’s recommendations include the following, grouped into four main areas of focus:
The EMA’s and EC’s Action Plan on ATMPs is available here.
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 290+ member organizations, including companies – especially small- to medium-sized enterprises (SMEs); academic/research institutions; non-profit organizations; patient advocacy organizations, and other members of the global advanced therapies community. The organization’s aim is to connect all parts of the innovation lifecycle to address current unmet medical 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.