The mRNA technology used for producing RGCC therapies is approved in Europe by EMA (European Medicines Agency), the equivalent to the FDA here in the US, as ATMPs (Advanced Therapy Medicinal Products)

ATMPs are advanced therapeutics for human use that are based on genes, tissues, or cells. ATMPs offer groundbreaking new opportunities for the treatment of disease and injury.

RGCC therapies are categorized as therapies for autologous use with minimal manipulation. This categorization means they are not “approved” by the FDA in the same way as homologous and complex manipulated therapies or medications.

Autologous means it was taken from an individual’s own tissues, cells, or DNA, the therapy is produced with minimal manipulation of those tissues, cells, or DNA, and administered back to the same individual.

This differs from therapies for homologous use, which means it is mass produced, and all patients get the same therapy. Think one-size-fits-all.

FDA approval is the gold standard homologous medications and medicinal products, or autologous but complex manipulated, NOT for autologous or single use and minimal manipulation.

Since every single RGCC therapy created is unique, EMA and the FDA do not “approve” the therapy, but the process used to produce the therapy or the laboratory producing the therapies itself.

Conclusion:

Since every single RGCC therapy created is unique, EMA and the FDA do not “approve” the therapy, but the process used to produce the therapy or the laboratory producing the therapies itself.