The presence of these technologies on the CAT agenda shows that they are entering formal scientific-recommendation processes concerning classification as ATMPs, but it does not mean clinical approval or marketing authorization.
The September meeting of EMA’s Committee for Advanced Therapies included requests for scientific recommendations involving technologies directly relevant to regenerative medicine and tissue engineering.
Exosomes and other extracellular vesicles are attracting growing scientific and commercial interest. The CAT activity is relevant because it shows these technologies being evaluated within a formal regulatory process for classification and scientific recommendation.
At its meeting of September 9–11, 2026, the European Medicines Agency’s Committee for Advanced Therapies (CAT) included on its agenda several requests for scientific recommendations concerning products that may fall within the definition of advanced therapy medicinal products (ATMPs). The CAT is the EMA committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products.
Items on the agenda included micronized autologous adipose tissue proposed as a local adjunctive treatment for refractory gastrointestinal fistulas; extracellular vesicles derived from human induced pluripotent stem cells for organ fibrosis; and two extracellular-vesicle platforms derived from trophoblast stem cells aimed at periodontal and peri-implant regeneration, alveolar bone regeneration and oral tissue repair.
In the agenda, these items appear under the scope of “ATMP scientific recommendation,” with the planned action listed as “for adoption.” The EMA itself notes that the agenda is a working document and that indications and scopes may change during the review process.
A meeting agenda is not a final opinion, evidence of efficacy or marketing authorization. The text should avoid any language that turns regulatory discussion into “approval.”
European Medicines Agency (EMA)
Identifier: EMA/CAT/203216/2026
Published by the source on September 8, 2026
Accessed on September 24, 2026
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