Prof. Dr. Martin Hildebrandt (San Bernardino, CA/ US), Mónica Freire (San Bernardino, CA/ US), Karen Moniz (San Bernardino, CA/ US), Dr. Julie G. Allickson (San Bernardino, CA/ US), Dr. Mickey B.C. Koh (San Bernardino, CA/ US), Eoin McGrath (San Bernardino, CA/ US), Dr. Ineke Slaper-Cortenbach (San Bernardino, CA/ US)
Background
ICCBBA develops ISBT 128 as an international code for substances of human origin, and brings together clinical, scientific, technical, and informatics experts, professional societies and observers from regulatory authorities and industry. Several Technical Advisory Groups (TAGs) contribute to the global implementation of ISBT 128. The Regenerative Medicine TAG (RMTAG) developed a terminology for tissue-engineered products (TEPs) and is now pursuing the development of a global labeling standard.
Methods
With the aim to develop an ISBT 128 standard for the labeling of TEPs with the involvement of facilities experienced in TEP manufacture, a survey was conducted among RMTAG members from September 19 to October 20, 2022. Acknowledging that TEPs can be regulated as Advanced Therapy Medicinal Products (ATMPs), biologics or medical devices, the survey included information on two labeling options: a labeling standard compatible with biologics regulations, and a labeling standard compatible with medical device regulations.
Participants were asked to provide background information on their facilities (products manufactured/received and applicable regulations) and which of the two proposed standards they would recommend for the labeling of TEPs.
Results
A total of 10 survey responses were obtained. Although participants affirmed that TEPs can be regulated as biologics, medical devices, or drugs, the majority (9 out of 10) representing TEPs manufacturers, blood, cellular therapy, and tissue facilities recommended developing a labeling standard compatible with biologics regulations.
Conclusion
Initial input from stakeholders indicates strong support for developing a labeling standard compatible with ATMP and biologics regulations rather than a labeling standard compatible with medical device regulations.
The RMTAG is actively reaching out to stakeholders from academia, industry and across geographical regions to ensure that the resulting standard truly meets users" expectations and effectively enables the traceability of TEPs worldwide.
Offenlegung Interessenkonflikt:
The authors declare that they do not have any conflicts of interest.