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Regulatory


ARM is the sector’s lead advocate for clear, predictable, and harmonized regulatory and review pathways for regenerative medicine and advanced therapy products in the U.S. and Europe.


ARM is the sector’s lead advocate for clear, predictable, and harmonized regulatory and review pathways for regenerative medicine and advanced therapy products in the U.S. and Europe.

Clear and predictable approval process regulation ensures product developers are able to understand the data and other requirements needed for approval and navigate the regulatory process without unnecessary delays or uncertainty.

And internationally harmonized regulation—the creation of globally consistent regulatory policies—facilitates the rapid and efficient development and introduction of regenerative medicine products across multiple markets worldwide, to the benefit of both manufacturers and patients.

ARM's Role in the Regulatory Environment

Review & Identify

Review existing scientific standards and initiatives to identify key regulatory issues and to provide information and support to product developers and regulatory agencies.

Advocate & Improve

Advocate for improved communication between product developers and regulatory bodies throughout the development pipeline.

Present & Discuss

Present at public meetings held by regulatory bodies to discuss best practices for translating scientific discoveries into innovative products for patients.

Submit Comments

Submit comments on the implications of proposed regulations for the regenerative medicine sector.

Maintain & Modify

Work with legislators and other policymakers to maintain and modify as appropriate the regulatory framework for regenerative medicine and advanced therapies.

ARM's Current Areas of Focus

Submitted Comments

March 2020

May 2020

April 2020

July 2020

August 2020