EMA: Warning about unregulated products in the EU

13 March 2025

EMA: Warning about unregulated products in the EU

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) which are currently being offered to patients in the European Union (EU). ATMPs are medicinal products which are based on genes, tissues or cells. They can offer important benefits to patients, if regulated. However, unregulated ATMPs have been marketed directly to patients, often when there is little to no evidence that the products work or are safe. The unregulated ATMPs could put patients at risk, causing serious side effects while not providing any benefits.

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