Unregulated advanced therapy medicinal products pose serious risks to health

EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union. ATMPs are medicinal products that are based on genes, tissues or cells. When these medicines are regulated (i.e. authorised via EMA or approved by a national authority), they can offer important benefits for patients. The European Union has established guidelines to ensure that ATMPs meet stringent safety ...