Cell, tissue and gene therapies offer significant potential to treat diseases with high unmet medical needs, and consist of human cell and tissue products for medical use and advanced therapy medicinal products (ATMPs).

One of the challenges in regulating cell, tissue, and gene therapies is to establish a clear definition that determines product classification for ATMPs and therefore the applicability of the corresponding regulations.

Considering the lower regulatory requirements applied to human cell and tissue products, it is of most importance that these definitions are clear and the corresponding classifications are transparent to regulatory authorities and sponsors.

This paper discusses the need to converge on the definitions and classification of ATMPs in order to foster reliance and/or recognition approaches to enable patients’ access to ATMPs.

Recommendations for convergence and reliance approaches for ATMPs

The recommendations outlined in the paper are to:

• Promote harmonization and recognition of product classification
• Facilitate reliance, recognition and collaboration across ATMP lifecycle
• Encourage harmonization of accreditation and standardization programs
• Waive in-country testing
• Use of “universal label” and electronic options
• Recognize GMP compliant certification
• Harmonize and streamline ATMP-GMP risk assessment